GE Healthcare Carescape Patient Data Module
FDA device recall Z-0060-2015 · posted 2014-10-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)
- Distribution
- 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
- Date initiated
- 2014-09-19
- Date posted
- 2014-10-09
- Date terminated
- 2016-09-13
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |