Recall Z-1298-2014— Draeger Medical Systems, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical Systems, Inc., initiated 2014-02-07, terminated 2015-08-17. It names 2 FDA 510(k) clearances: K093632, K093633. Product: Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.. Reason: The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected..
- Recalling firm
- Draeger Medical Systems, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-02-07
- Terminated
- 2015-08-17
- 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
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
Reason for recall
The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS 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.