GE Healthcare Carescape Patient Data Module

Date

Oct. 15, 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 Patient Data Module

Reason

GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

Distribution pattern

Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.

Quantity

68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)

Codes and lots

Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR SA307080497GA SA307080498GR SA307080499GA SA307080502GR SA307080504GR SA307080508GR SA307080509GA SA307080510GR SA307080513GA SA307080520GR SA307080521GA SA307080522GR SA307080524GA SA307080525GR SA307080526GR SA307080533GR SA307105145GA SA307110544GA SA307110548GR SA307110556GA SA307110559GR SA307110560GR SA307110572GR SA307110575GR SA307110579GR SA307120587GR SA307140598GA SA307140599GR SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140614GA SA307140615GA SA307140618GR SA307140619GA SA307140621GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140637GA SA307140640GR SA307140642GA SA307150645GA SA307150651GA SA307150655GA SA307150656GA SA307150671GR SA307150675GA SA307150681GR SA307180694GR SA307180695GA SA307180696GR SA307180697GR SA307180698GA SA307180699GR SA307180701GA SA307180702GR SA307180704GR SA307180705GR SA307180706GR SA307180707GA SA307180708GA SA307190717GR SA307190722GA SA307190727GA SA307190729GR SA307190730GR SA307190731GR SA307190732GR SA307190733GA SA307190734GR SA307190736GR SA307190737GR SA307190738GR SA307190739GR SA307190741GR SA307190742GR SA307190743GR SA307190744GR SA307190745GR SA307190749GR SA307190750GR SA307190751GA SA307190752GA SA307190753GA SA307190754GA SA307190755GR SA307190756GR SA307190757GR SA307190759GA SA307190760GA SA307190761GA SA307190762GA SA307190764GR 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Recall started

Sept. 19, 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 9/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 336107 dated September 18, 2014. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing and Healthcare Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions , Affected Product Details, Product Correction and Contact Information. For questions they can contact Technical Support at 1-800-558-70444 or your local Service Representative.

Recall number

Z-0060-2015

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

Source: FDA · Medical device enforcement report, recall number Z-0060-2015. The agency record governs; check it and the company before acting.