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

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is require — recall Z-1577-2016

U.S. FDA — Device Enforcement · United States · 2016-04-13 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1577-2016
Date of alert: 2016-04-13
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic
Product category: device
Product type: Devices

Reported risk: Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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