Class II — Philips Medical Systems, Inc.
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 188,520 devices |
| Distribution | Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey. |
| Initiated | 2014-04-04 |
| Classified | 2014-05-16 |
| Terminated | 2017-11-07 |
| Recall number | Z-1628-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems, Inc. (Z-1628-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67923/
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