FDA Device recall Z-1606-2015
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50)
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50) by Ge Healthcare, citing 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 monito….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1606-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-04 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CO, MI, WI |
Product
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Reason
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
Identifiers
| code_info | Mfg Lot or Serial # SED12394685GA SED12394688GA SED12404710GA SED12404711GA SED12404713GA SED12404716GA SED12404…Mfg Lot or Serial # SED12394685GA SED12394688GA SED12404710GA SED12404711GA SED12404713GA SED12404716GA SED12404718GA SED12404720GA SED12404721GA SED12404722GA SED12404723GA SED12404725GA SED12445258GA SED12445259GA SED12445261GA SED12445262GA SED12445264GA SED12445265GA SED12445266GA SED12445268GA SED12445269GA SED12445298GA SED12445299GA SED12445309GA SEW12265533HA SEW13286489HA SEW14095097HA SEW14095105HA SEW14105496HA SEW14105497HA SEW14105502HA SEW14105503HA SEW14160623HA SEW14160626HA SEW14171213HA SEW14171313HA SEW14171314HA SEW14171315HA SEW14171317HA SEW14171319HA SEW14171320HA SEW14171321HA SKA14062508GA SKA14062511GA SKA14284377GA SKA14284378GA SKA14284382GA SKA14284385GA SKA14284388GA SKA14284393GA SKA14284394GA SKA14284395GA SKA14365356GA SKA14365375GA SKA14365378GA SKA14365380GA SKA14365382GA SKA14487159GA SKA14487160GA SKA14487161GA SKA14487162GA SKA14487163GA SKA14487165GA SKA14487166GA SKA14487168GA SKA1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1606-2015%22
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