FDA Device recall Z-2085-2014
GE Healthcare, CARESCAPE Monitor B850, B650 or B450
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B850, B650 or B450 by Ge Healthcare, citing partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software v….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2085-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-13 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reason
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
Identifiers
| code_info | CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 P…CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146 SED09130290GP 2042395-001+889146 SED09130291GP 2042395-001+889146 SED09130296GP 2042395-001-884783 SED09130298GP 2042395-001+889146 SED09130302GP 2042395-001+889148 SED09130304GP 2042395-001+887796 SED09130307GP 2042395-001-885430 SED09130312GP 2042395-001+889880 SED09180333GP 2042395-001+889148 SED09180334GP 2042395-001+887796 SED09180338GP 2042395-001+889148 SED09180341GP 2042395-001+889880 SED09220344GP 2042395-001+889880 SED09220345GP 2042395-001+889880 SED09220346GP 2042395-001+889880 SED09220347GP 2042395-001+889880 SED09220348GP 2042395-001+889880 SED09220350GP 2042395-001+889880 SED09220355GP 2042395-001+889880 SED09220357GP 2042395-001+889880 SED09220358GP 2042395-001+889880 SED09220365GP 2042395-001+889880 SED0922036 |
|---|
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-2085-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.