Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1628-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-04-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1628-2014
Date of alert
2014-04-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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