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

Recall Z-1307-2015 — Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2

U.S. FDA — Device Enforcement · United States · 2014-11-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1307-2015
Date of alert: 2014-11-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: VCG battery ignited in a VCG unit when recharging.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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