Quantum Pump Console — Class I medical device recall Z-2238-2019
Terminated recall by Spectrum Medical Ltd., reported 2019-09-04, distributed in NY, OH, VA, WA. Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in
| Recall number | Z-2238-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Medical Ltd., Gloucester, N/A, United Kingdom |
| Recall initiated | 2019-05-29 |
| Classified | 2019-08-23 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2020-08-21 |
| Distributed | NY, OH, VA, WA |
| Countries outside the US | NL |
| Serial numbers | PH1000005, PH1000020, PH1000027, PH1000030, PH1000077, PH1000081, PH1000082, PH1000086, PH1000087, PH1000093, PH1000100, PH1000101, PH1000102, PH1000103, PH1000109, PH1000110, PH1000112, PH1000113, PH1000114, PH1000115, PH1000120, PH1000127, PH1000129, PH1000131, PH1000132 and 83 more |
Product
Quantum Pump Console
Reason for recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2238-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.