Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

FDA Recall Z-2343-2015 · Posted 2015-08-14

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2015-07-13
Date Terminated2017-03-01
Product Quantity2081

Reason for Recall

The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Firm Action

Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

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.

↑