FDA Device recall Z-2201-2013
GE Healthcare, CARESCAPE Monitor B850
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B850 by Ge Healthcare, citing GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management sof….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2201-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-07-20 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Reason
GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
Identifiers
| code_info | Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 66939…Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8 CZC0044VZB CZC0070P7B CZC0070P7G CZC0133FMM CZC0133FMS CZC0133FN7 CZC0182JL2 CZC0182JL8 CZC02211YN CZC0249CL3 CZC0249CL5 CZC0249CL7 CZC0249CLF CZC0249CLK CZC03336CT CZC03336D1 CZC03336D6 CZC0334KJ5 CZC0334KJ6 CZC0366ZR0 CZC0468W4H CZC1027W82 CZC1027W85 CZC1027W86 CZC1027W8C CZC1129Z65 CZC116B2N7 CZC9313455 CZC0016T0H CZC0016T0T CZC0044VY7 CZC0044VY9 CZC0044VYD CZC0044VYM CZC0044VYP CZC0044VYQ CZC0044VYR CZC0044VYV CZC0044VZ2 CZC0044VZ9 CZC0044VZC CZC0133FMJ CZC0207NVR CZC0207NVS CZC02211YD CZC02211YG CZC02211YT CZC0249CLJ CZC0322T5K CZC0334KJM CZC0369HKQ CZC1069WFK CZC1069WFT CZC1129Z6D CZC1129Z6Y CZC1129Z73 CZC94890S5 CZC94890S7 CZC94890SD CZC0322T5G CZC0322T5J CZC0 |
|---|
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-2201-2013%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.