Recall Z-2343-2015— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2015-07-13, terminated 2017-03-01. It names 2 FDA 510(k) clearances: K093632, K093633. Product: PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.. Reason: The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-07-13
- Terminated
- 2017-03-01
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K093632 — INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
- K093633 — INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.