FDA · Medical device recall

ApexPro Telemetry System… and 2 more products

Jan. 1, 2020 Class II

Date: Jan. 1, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
Distribution pattern: Worldwide distribution.

3 products in this recall

ApexPro Telemetry System…

Product: ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
Quantity: 11347 devices
Codes and lots: Serial Numbers: Mfg. 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00840682109260SEE09310383GA SEE09310384GA 00840682109260SEE09310384GA SEE09310387GA 00840682109260SEE09310387GA SEE09310389GA…
Recall started: Nov. 12, 2019
Device type: Detector And Alarm, Arrhythmia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.
Recall number: Z-0725-2020

CIC Pro Clinical Information Center Central Station…

Product: CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
Quantity: 41848 units
Codes and lots: Serial Numbers: A0GU1745G A0GU1746G A0GU1747G A0GU1748G A0GU1749G A0GU1750G A0GU1751G A0GU1752G A0GU1756G A0GU1757G A0GU1758G A0GU1759G A0GU1766G A0GU1769G A0GU1770G A0GU1771G A0GU1775G A0GU1788G A0GU1789G A0GU1796G A0GU1799G A0GU1801G A0GU1802G A0GU1805G A0GU1806G A0GU1807G A0GU1808G A0GU1809G A0GU1810G A0GU1813G A0GU1814G A0GU1816G A0GU1823G A0GU1824G A0GU1825G A0GU1826G A0GU1827G A0GU1829G A0GU1830G A0GU1831G A0GU1832G A0GU1833G A0GU1834G A0GU1835G A0GU1839G A0GU1840G A0GU1841G A0GU1842G A0GU1845G A0GU1846G A0GU1847G A0GU1848G A0GU1849G A0GU1850G A0GU1851G A0GU1852G A0GU1853G A0GU1854G A0GU1855G A0GU1856G A0GU1857G A0GU1858G A0GU1859G A0GU1860G A0GU1865G A0GU1866G A0GU1867G A0GU1868G A0GU1869G A0GU1870G A0GU1871G A0GU1872G A0GU1873G A0GU1874G A0GU1875G A0GU1876G A0GU1877G A0GU1878G A0GU1881G A0GU1882G A0GU1885G A0GU1887G A0GU1888G A0GU1894G A0GU1895G A1GQ0198G A1GQ0199G A1GQ0200G A1GQ0201G A1GQ0202G A1GQ0203G A1GQ0204G A1GQ0205G A1GQ0206G A1GQ0207G A1GQ0208G A1GQ0209G A1GQ0210G A1GQ0211G A1GQ0212G A1GQ0213G A1GQ0214G A1GQ0216G A1GQ0217G A1GQ0218G A1GQ0219G A1GQ0220G A1GQ0221G A1GQ0222G A1GQ0223G A1GQ0224G A1GQ0225G A1GQ0226G A1GQ0227G A1GQ0228G A1GQ0229G A1GQ0230G A1GQ0231G A1GQ0233G A1GQ0234G A1GQ0235G A1GQ0236G A1GQ0238G A1GQ0239G A1GQ0244G A1GQ0245G A1GQ0246G A1GQ0247G A1GQ0248G A1GQ0249G A1GQ0250G A1GQ0251G A1GQ0252G A1GQ0253G A1GQ0254G A1GU0230G A1GU3167G A1GU3168G A1GU3177G A1GU3178G A1GU3189G A1GU3199G A1GU3200G A23F1180G A23F1181G A23F1182G A23F1185G A23F1186G A23F1187G A23F1188G A23F1189G A23F1190G A23F1191G A23F1195G A23F1196G A23F1197G A23F1198G A23F1199G A23F1202G A23F1206G A23F1208G A23F1209G A23F1210G A23F1211G A23F1212G A23F1213G A23F1214G A23F1215G A23F1218G A23F1219G A23F1220G A23F1223G A23F1224G A23F1225G A23F1226G A23F1227G A23F1228G A23F1229G A23F1230G A23F1231G A23F1232G A23F1233G A23F1234G A23F1235G A23F1236G A23F1237G A23F1239G A23F1240G A23F1246G A23F1247G A23F1248G A23F1249G A23F1250G A23F1251G A23F1252G A23F1253G A23F1257G A23F1258G A23F1260G A23F1263G A23F1264G A23F1265G A23F1266G A23F1267G A23F1269G A23F1272G A23F1273G A23F1274G A23F1275G A23F1276G A23F1277G A23F1278G A23F1279G A23F1280G A23F1281G A23F1282G A23F1283G A23F1284G A23F1285G A23F1286G A23F1287G A23F1288G A23F1289G A23F1290G A23F1291G A23F1292G A23F1293G A23F1294G A23F1295G A23F1296G A23F1297G A23F1298G A34T1762G A34T1765G A34T1768G A34T1770G A34T1779G A34T1781G A34T1784G A34T1785G A34T1787G A34T1788G A34T1789G A34T1790G A34T1791G A34T1792G A34T1803G A34T1804G A34T1806G A34T1807G A34T1808G A34T1809G A34T1810G A34T1812G A34T1815G A34T1816G A34T1817G A34T1819G A34T1822G A34T1825G A34T1826G A34T1827G A34T1829G A34T1830G A34T1831G A34T1832G A34T1839G A34T1840G A34T1841G A34T1842G A34T1843G A34T1846G A34T1848G A34T1853G A34T1861G A34T1864G A34T1870G A34T1872G A34T1873G A34T1874G A34T1879G A34T1880G A34T1883G A34T1884G A34T1896G A34T1897G A34T1899G A34T1900G A34T1903G A34T1904G A34T1906G A34T1907G A34T1911G A34T1912G A34T1913G A34T1915G A34T1917G A34T1920G A34T1921G A34T1923G A34T1924G A34T1925G A34T1926G A34T1927G A44T4541G A44T4542G A44T4543G A44T4544G A44T4545G A44T4546G A44T4547G A44T4548G A44T4550G A44T4551G A44T4552G A44T4553G A44T4554G A44T4555G A44T4556G A44T4557G A44T4558G A44T4559G A44T4561G A44T4563G A44T4564G A44T4565G A44T4566G A44T4567G A44T4568G A44T4573G A44T4574G A44T4575G A44T4576G A44T4580G A44T4581G A44T4582G A44T4583G A44T4584G A44T4585G A44T4586G A44T4587G A44T4588G A44T4589G A44T4590G A44T4591G A44T4592G A44T4593G A44T4594G A44T4595G A44T4596G A44T4597G A44T4598G A44T4599G A44T4604G A44T4605G A44T4606G A44T4607G A44T4609G A44T4610G A44T4611G A44T4612G A44T4613G A44T4615G A44T4616G A44T4617G A44T4618G A44T4619G A44T4621G A44T4622G A44T4623G A44T4624G A44T4625G A44T4626G A44T4627G A44T4628G A44T4629G A44T4630G A44T4631G A44T4632G A44T4634G A44T4635G A44T4636G A44T4637G A44T4638G A44T4639G A44T4640G A44T4641G A44T4643G A44T4645G A44T4646G A44T4647G A44T4648G A44T4649G A44T4650G A44T4651G A44T4652G A44T4653G A44T4654G A44T4655G A44T4656G A44T4657G A44T4658G A44T4659G A44T4660G A44T4661G A44T4662G A44T4664G A44T4665G A44T4666G A44T4667G A44T4668G A44T4669G A44T4672G A44T4675G A44T4676G A44T4677G A44T4678G A44T4679G A44T4681G A44T4682G A44T4683G A44T4684G A44T4685G A44T4686G A44T4687G A44T4688G A44T4689G A44T4690G A44T4691G A44T4692G A44T4693G A44T4695G A44T4696G A44T4697G A44T4701G A44T4702G A44T4703G A44T4704G A44T4705G A44T4706G A44T4707G A44T4710G A44T4713G A44T4714G A44T4715G A44T4716G A44T4717G A44T4718G A44T4719G A44T4720G A44T4725G A44T4726G A44T4727G A44T4728G A44T4732G A44T4739G A9GU0008G A9GU0365G A9GU0366G A9GU0367G A9GU0369G A9GU0371G A9GU0372G A9GU0373G A9GU0374G A9GU0377G A9GU0378G A9GU0379G A9GU0380G A9GU0381G A9GU0382G A9GU0383G A9GU0384G A9GU0385G A9GU0386G A9GU0387G A9GU0388G A9GU0389G A9GU0390G A9GU0391G A9GU0392G A9GU0393G A9GU0394G A9GU0395G A9GU0396G A9GU0397G A9GU0398G A9GU0399G A9GU0400G A9GU0401G A9GU0402G A9GU0403G A9GU0404G A9GU0405G A9GU0406G A9GU0407G A9GU0408G A9GU0409G A9GU0410G A9GU0411G A9GU0412G A9GU0413G A9GU0414G A9GU0415G A9GU0416G A9GU0417G A9GU0418G A9GU0420G A9GU0421G A9GU0422G A9GU0423G A9GU0424G A9GU0425G A9GU0426G A9GU0427G AA104150001GA AA104150002GA AA104160005GA AA104160007GA AA104160008GA AA104160009GA AA104160010GA AA104160011GA AA104160012GA AA104160015GA AA104160016GA AA104170017GA AA104170018GA AA104170019GA AA104170020GA AA104170021GA AA104170022GA AA104170023GA AA104170024GA AA104170025GA AA104170026GA AA104170027GA AA104170028GA AA104170029GA AA104170030GA AA104170031GA AA104180032GA AA104180033GA AA104180034GA AA104180035GA AA104180036GA AA104180037GA AA104180038GA AA104180039GA AA104180040GA AA104180041GA AA104180042GA AA104180043GA AA104180045GA AA104180046GA AA104180047GA AA104180049GA AA104180050GA AA104180051GA AA104180052GA AA104180053GA AA104180054GA AA104180055GA AA104190057GA AA104190060GA AA104190061GA AA104190062GA AA104190063GA AA104190064GA AA104190065GA AA104190066GA AA104190069GA 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AA104210184GA AA104210185GA AA104210186GA AA104210187GA AA104210188GA AA104210190GA AA104210191GA AA104210192GA AA104220193GA AA104220201GA AA104220202GA AA104220204GA AA104220205GA AA104220206GA AA104220207GA AA104220211GA AA104220212GA AA104220215GA AA104220216GA AA104220217GA AA104220218GA AA104220219GA AA104240226GA AA104240227GA AA104240228GA AA104240229GA AA104240230GA AA104240231GA AA104240232GA AA104240233GA AA104240234GA AA104240235GA AA104240236GA AA104240237GA AA104240238GA AA104240239GA AA104240240GA AA104240241GA AA104240242GA AA104240243GA AA104240244GA AA104240245GA AA104240246GA AA104240247GA AA104240248GA AA104240249GA AA104240250GA AA104240251GA AA104240252GA AA104240253GA AA104240254GA AA104240255GA AA104240256GA AA104240257GA AA104240258GA AA104240259GA AA104240260GA AA104240262GA AA104240263GA AA104240264GA AA104240265GA AA104240266GA AA104240267GA AA104240268GA AA104240269GA AA104240270GA AA104240271GA AA104240272GA AA104240273GA AA104240274GA AA104240275GA AA104240276GA AA104240277GA AA104240278GA AA104240279GA AA104240280GA AA104240281GA AA104240283GA AA104240284GA AA104240285GA AA104240286GA AA104240287GA AA104240288GA AA104240289GA AA104240290GA AA104240293GA AA104240294GA AA104240295GA AA104240296GA AA104240297GA AA104240298GA AA104240299GA AA104240300GA AA104250301GA AA104250302GA AA104250303GA AA104250304GA AA104250305GA AA104250306GA AA104250307GA AA104250308GA AA104250309GA AA104250310GA AA104250311GA AA104250312GA AA104250313GA AA104250315GA AA104250316GA AA104250319GA AA104250320GA AA104250321GA AA104250322GA AA104250323GA AA104250324GA AA104250325GA AA104250326GA AA104250327GA AA104250328GA AA104250329GA AA104250336GA AA104250338GA AA104250339GA AA104250340GA AA104250343GA AA104250344GA AA104250345GA AA104250346GA AA104250347GA AA104250348GA AA104250349GA AA104250350GA AA104250351GA AA104250352GA AA104250353GA AA104250354GA AA104250355GA AA104250356GA AA104250359GA AA104250360GA AA104250361GA AA104250362GA AA104250363GA 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AA104330635GA AA104330636GA AA104330637GA AA104330638GA AA104330642GA…
Recall started: Nov. 12, 2019
Device type: Detector And Alarm, Arrhythmia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.
Recall number: Z-0726-2020

CARESCAPE Central Station…

Product: CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
Quantity: 10661 units
Codes and lots: Serial Numbers: SGJ14180008GP SGJ14180009GP SGJ14220011GA SGJ14220014GA SGJ14220015GA SGJ14220016GA SGJ14220017GA SGJ14220019GA SGJ14220023GA SGJ14220024GA SGJ14220026GA SGJ14220027GA SGJ14220029GA SGJ14220032GA SGJ14220033GA SGJ14220034GA SGJ14220037GA SGJ14220038GA SGJ14220041GA SGJ14430047GA SGJ14430048GA SGJ14430051GA SGJ14430052GA SGJ14430055GA SGJ14430057GA SGJ14430060GA SGJ14430061GA SGJ14440067GA SGJ14440071GA SGJ14440073GA SGJ14440077GA SGJ14440078GA SGJ14440081GA SGJ14440082GA SGJ14440085GA SGJ14440086GA SGJ14450092GA SGJ14450094GA SGJ14450095GA SGJ14450096GA SGJ14450097GA SGJ14450098GA SGJ14450099GA SGJ14450101GA SGJ14450104GA SGJ14450105GA SGJ14450106GA SGJ14450107GA SGJ14450109GA SGJ14450141GA SGJ14450142GA SGJ14450145GA SGJ14450146GA SGJ14450147GA SGJ14450152GA SGJ14450155GA SGJ14450156GA SGJ14450159GA SGJ14450161GA SGJ14450162GA SGJ14450163GA SGJ14450164GA SGJ14450168GA SGJ14450170GA SGJ14450171GA SGJ14450173GA SGJ14450176GA SGJ14450177GA SGJ14450179GA SGJ14480180GA SGJ14480181GA SGJ14480182GA SGJ14480183GA SGJ14480184GA SGJ14480186GA SGJ14480187GA SGJ14480188GA SGJ14480189GA SGJ14480192GA SGJ14480193GA SGJ14480194GA SGJ14480195GA SGJ14480196GA SGJ14480197GA SGJ14480198GA SGJ14490200GA SGJ14490202GA SGJ14490211GA SGJ14490213GA SGJ14490214GA SGJ14490215GA SGJ14490225GA SGJ14490230GA SGJ14490231GA SGJ14490232GA SGJ14490233GA SGJ14490235GA SGJ14490236GA SGJ14490237GA SGJ14490238GA SGJ14490239GA SGJ14490240GA SGJ14490241GA SGJ14490242GA SGJ14490243GA SGJ14490244GA SGJ14490246GA SGJ14490247GA SGJ14490248GA SGJ14490249GA SGJ14490251GA SGJ14490252GA SGJ14490253GA SGJ14490254GA SGJ14490255GA SGJ14490256GA SGJ14490257GA SGJ14490258GA SGJ14490260GA SGJ14490263GA SGJ14490265GA SGJ14490266GA SGJ14490267GA SGJ14490269GA SGJ14490272GA SGJ14490275GA SGJ14490276GA SGJ14490277GA SGJ14490278GA SGJ14490284GA SGJ14490287GA SGJ14490288GA SGJ14500289GA SGJ14500290GA SGJ14500291GA SGJ14500292GA SGJ14500293GA SGJ14500294GA SGJ14500295GA SGJ14500296GA SGJ14500297GA SGJ14500298GA SGJ14500300GA SGJ14500301GA SGJ14500302GA SGJ14500303GA SGJ14500304GA SGJ14500305GA SGJ14500306GA SGJ14500307GA SGJ14500308GA SGJ14500309GA SGJ14500310GA SGJ14500311GA SGJ14500312GA SGJ14500313GA SGJ14500314GA SGJ14500315GA SGJ14500316GA SGJ14500317GA SGJ14500318GA SGJ14500319GA SGJ14500320GA SGJ14500321GA SGJ14500322GA SGJ14500323GA SGJ14500324GA SGJ14500325GA SGJ14500326GA SGJ14500327GA SGJ14500328GA SGJ14500329GA SGJ14500330GA SGJ14500331GA SGJ14500332GA SGJ14500334GA SGJ14500335GA SGJ14500336GA SGJ14500339GA SGJ14510340GA SGJ14510341GA SGJ14510342GA SGJ14510343GA SGJ14510344GA SGJ14510348GA SGJ14510349GA SGJ14520353GA SGJ14520354GA SGJ14730081SA SGJ15010366GA SGJ15010369GA SGJ15010370GA SGJ15010371GA SGJ15010373GA SGJ15010377GA SGJ15010379GA SGJ15010383GA SGJ15010384GA SGJ15010386GA SGJ15010388GA SGJ15010390GA SGJ15010392GA SGJ15010394GA SGJ15010405GA SGJ15010406GA SGJ15010407GA SGJ15010408GA SGJ15010409GA SGJ15010410GA SGJ15010411GA SGJ15010412GA SGJ15010413GA SGJ15010414GA SGJ15010416GA SGJ15010417GA SGJ15010418GA SGJ15010424GA SGJ15010430GA SGJ15010431GA SGJ15010432GA SGJ15010433GA SGJ15010434GA SGJ15010437GA SGJ15010438GA SGJ15010439GA SGJ15010443GA SGJ15010444GA SGJ15010445GA SGJ15010451GA SGJ15010452GA SGJ15010455GA SGJ15010457GA SGJ15010459GA SGJ15010460GA SGJ15020461GA SGJ15020462GA SGJ15020465GA SGJ15020466GA SGJ15020467GA SGJ15020469GA SGJ15020470GA SGJ15020471GA SGJ15020472GA SGJ15020473GA SGJ15020474GA SGJ15020475GA SGJ15020476GA SGJ15020477GA SGJ15020479GA SGJ15020480GA SGJ15020481GA SGJ15020482GA SGJ15020483GA SGJ15020485GA SGJ15020486GA SGJ15020487GA SGJ15020488GA SGJ15020489GA SGJ15020490GA SGJ15020491GA SGJ15020492GA SGJ15020493GA SGJ15020495GA SGJ15020496GA SGJ15020497GA SGJ15020498GA SGJ15020499GA SGJ15020502GA SGJ15020503GA SGJ15020504GA SGJ15020506GA SGJ15020508GA SGJ15020509GA SGJ15020516GA SGJ15020519GA SGJ15020520GA SGJ15040523GA SGJ15040524GA SGJ15040525GA SGJ15040527GA SGJ15040528GA SGJ15040531GA SGJ15040532GA SGJ15040533GA SGJ15040534GA SGJ15040536GA SGJ15040538GA SGJ15040541GA SGJ15040542GA SGJ15040543GA SGJ15040544GA SGJ15040545GA SGJ15040550GA SGJ15040551GA SGJ15040552GA SGJ15040553GA SGJ15040554GA SGJ15040555GA SGJ15040557GA SGJ15040558GA SGJ15040559GA SGJ15040560GA SGJ15040561GA SGJ15040562GA SGJ15040563GA SGJ15040564GA SGJ15040565GA SGJ15040569GA SGJ15040570GA SGJ15040571GA SGJ15040572GA SGJ15040573GA SGJ15040575GA SGJ15040576GA SGJ15040577GA SGJ15040578GA SGJ15040579GA SGJ15040580GA SGJ15040581GA SGJ15040582GA SGJ15040583GA SGJ15040584GA SGJ15040586GA SGJ15040588GA SGJ15040589GA SGJ15040590GA SGJ15040591GA SGJ15040592GA SGJ15040593GA SGJ15040594GA SGJ15040597GA SGJ15040598GA SGJ15040599GA SGJ15040602GA SGJ15040603GA SGJ15040604GA SGJ15040605GA SGJ15040606GA SGJ15040607GA SGJ15040608GA SGJ15040609GA SGJ15040611GA SGJ15050612GA SGJ15050615GA SGJ15050616GA SGJ15050617GA SGJ15050618GA SGJ15050619GA SGJ15050620GA SGJ15050621GA SGJ15050622GA SGJ15050623GA SGJ15050624GA 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Recall started: Nov. 12, 2019
Device type: Detector And Alarm, Arrhythmia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.
Recall number: Z-0727-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0725-2020, Z-0726-2020, Z-0727-2020. The agency record governs; check it and the company before acting.

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