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Terminated

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

FDA Recall Z-0827-2016 · Posted 2016-02-25

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2016-02-04
Date Terminated2020-04-01
Product Quantity2553

Reason for Recall

The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.

Firm Action

Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CAREDrager Medical AG & Co. Kgaa · 2010-04-05K093633INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CAREDraegerwerk AG & CO Kgaa · 2010-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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