GE Healthcare…

Date

July 30, 2014

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

Product

GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

Reason

Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.

Distribution pattern

Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.

Quantity

41,992 (20,509 US; 21,483 OUS)

Codes and lots

CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146 SED09130290GP 2042395-001+889146 SED09130291GP 2042395-001+889146 SED09130296GP 2042395-001-884783 SED09130298GP 2042395-001+889146 SED09130302GP 2042395-001+889148 SED09130304GP 2042395-001+887796 SED09130307GP 2042395-001-885430 SED09130312GP 2042395-001+889880 SED09180333GP 2042395-001+889148 SED09180334GP 2042395-001+887796 SED09180338GP 2042395-001+889148 SED09180341GP 2042395-001+889880 SED09220344GP 2042395-001+889880 SED09220345GP 2042395-001+889880 SED09220346GP 2042395-001+889880 SED09220347GP 2042395-001+889880 SED09220348GP 2042395-001+889880 SED09220350GP 2042395-001+889880 SED09220355GP 2042395-001+889880 SED09220357GP 2042395-001+889880 SED09220358GP 2042395-001+889880 SED09220365GP 2042395-001+889880 SED09220367GP 2042395-001+889880 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Recall started

June 13, 2014

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

Consignees were sent on 6/13/2014 a GE Healthcare "Urgent Medical Device Correction" letter #36103, 36104 and 36105 dated June 6, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information. Consignees were advised to contact Technical Support at 800-558-7044 in regard to questions on this recall.

Recall number

Z-2085-2014

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

Source: FDA · Medical device enforcement report, recall number Z-2085-2014. The agency record governs; check it and the company before acting.