Recall record at a glance
| Official record | Z-1606-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | May 20, 2015 |
| Recall initiation date | May 4, 2015 |
| Quantity | 110 (83 units US, 27 units OUS) |
| Location | Waukesha, WI, United States |
Official product description
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Why the product was recalled
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
Distribution information
Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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