GE Healthcare — Class II medical device recall Z-1606-2015
Terminated recall by GE Healthcare, reported 2015-05-20, distributed in CO, MI, WI. The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in som
| Recall number | Z-1606-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-05-04 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-09-15 |
| Distributed | CO, MI, WI |
| Countries outside the US | BE, FI, NL |
| Serial numbers | SED11067045GA, SED11229605GA, SED11239640GA, SED11239644GA, SED11239645GA, SED11239663GA, SED11239664GA, SED11239668GA, SED11239669GA, SED11239678GA, SED11239679GA, SED11239680GA, SED12394559GA, SED12394685GA, SED12394688GA, SED12404710GA, SED12404711GA, SED12404713GA, SED12404716GA, SED12404718GA, SED12404720GA, SED12404721GA, SED12404722GA, SED12404723GA, SED12404725GA and 85 more |
Product
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
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 patient¿s condition and delayed or missed life sustaining patient treatment
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1606-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.