FDA Device recall Z-0550-2022
OXY-1 System, Model Number 001-0500-001
- FDA Device
- Class I
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class I recall of OXY-1 System, Model Number 001-0500-001 by Abiomed, citing the firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0550-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-12-14 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abiomed |
| Distribution | FL, GA, IN, MD, NC, PA, TX |
Product
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Reason
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
Identifiers
| code_info | UDI 00860001797909 Software Version Number V-1.3.15.0, V-1.4.6.0 and V.1.4.8.0 Serial Numbers 20200231-04 202002…UDI 00860001797909 Software Version Number V-1.3.15.0, V-1.4.6.0 and V.1.4.8.0 Serial Numbers 20200231-04 20200249-01 20200249-05 20200309-02 20200339-01 20200339-03 20200352-01 20200442-01 20200442-02 20200442-05 20210768-01 20210795-02 20210870-01 20210880-01 20210890-01 20210894-01 20210895-01 20210896-01 20210897-01 20210795-04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0550-2022%22
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