FDA Device recall Z-1628-2014
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors by Philips Medical Systems, citing the risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1628-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-04 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
Reason
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
Identifiers
| code_info | Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003…Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0. |
|---|
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-1628-2014%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.