FDAFDA · Food and drugs·Recall number Z-0060-2015
GE Healthcare Carescape Patient Data Module
Published October 15, 2014 · Recall initiated: September 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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 SA307190768GR SA307190769GR SA307190770GR SA307190771GR SA307190772GA SA307190773GA SA307190774GR SA307190775GR SA307200776GA SA307200777GR SA307200784GR SA307200788GR SA307200791GA SA307200792GA SA307200793GA SA307200794GA SA307200795GA SA307200796GA SA307200797GA SA307200798GA SA307200799GA SA307200800GR SA307200801GA SA307200802GA SA307200803GA SA307200804GA SA307200805GA SA307210815GA SA307210818GA SA307210819GR SA307210820GR SA307210821GA SA307210824GA SA307210825GA SA307210826GA SA307210827GA SA307210828GR SA307210829GA SA307210832GA SA307210833GA SA307210836GR SA307210837GA SA307210838GA SA307210839GR SA307210841GR SA307210843GA SA307210858GA SA307210863GA SA307220869GA SA307220870GA SA307220872GA SA307220875GA SA307220877GA SA307220878GA SA307220879GA SA307220880GR SA307220888GA SA307220890GR SA307220892GR SA307220893GA SA307220898GR SA307220900GR SA307220901GR SA307220902GA SA307220903GR SA307220904GR SA307220908GA SA307220914GR SA307220920GR SA307220923GA SA307220931GR SA307220932GR SA307220935GA SA307220936GA SA307220937GA SA307220938GA SA307220941GA SA307220942GA SA307220944GA SA307220945GA SA307220946GA SA307220947GR SA307220948GA SA307220950GA SA307220951GA SA307220952GA SA307220953GA SA307220954GA SA307220955GA SA307220956GA SA307220957GA SA307220958GA SA307220959GA SA307220961GA SA307220963GA SA307220978GA SA307220983GR SA307220986GA SA307220987GA SA307220988GA SA307220990GR SA307220996GR SA307220999GR SA307221000GA SA307221001GA SA307221003GA SA307221004GA SA307221006GA SA307221007GR SA307221008GA SA307221009GA SA307221010GA SA307221011GA SA307221012GA SA307221013GR SA307221014GA SA307221016GA SA307221018GA SA307221026GR SA307221027GA SA307221028GA SA307221030GA SA307221033GA SA307221035GA SA30
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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