Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient… — Class II medical device recall Z-1628-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-05-28, distributed nationwide. The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date o
| Recall number | Z-1628-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-04-04 |
| Classified | 2014-05-16 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2017-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, CZ, DE, DK, EE, FI, FR, GR, HU, IT, JP, NL, NO, PL, RO, RU, SE, SK, TR |
| Quantity | 188,520 devices |
| Reason classes | device malfunction |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1628-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.