GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
FDA device recall Z-1606-2015 · posted 2015-05-12 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 110 (83 units US, 27 units OUS)
- Distribution
- Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
- Date initiated
- 2015-05-04
- Date posted
- 2015-05-12
- Date terminated
- 2015-09-15
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE MONITOR B450 (K132533) | GE Healthcare Finland Oy | 2013-12-04 |
| CARESCAPE MONITOR B650 (K131223) | GE Healthcare Finland Oy | 2013-08-28 |
| CARESCAPE MONITOR B850 (K131414) | GE Healthcare Finland Oy | 2013-08-28 |
| CARESCAPE MONITOR B650 (K102239) | GE Healthcare Finland Oy | 2010-10-18 |
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |