Class I — Spectrum Medical Ltd.
| Recalling firm | Spectrum Medical SRL |
|---|---|
| Registered facility | SPECTRUM MEDICAL SRL (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. |
| Product | Quantum Pump Console |
| Quantity | 108 units (8 US, 100 OUS) |
| Distribution | US distribution to NY, OH, VA, WA. International distribution to the Netherlands. |
| Initiated | 2019-05-29 |
| Classified | 2019-08-23 |
| Terminated | 2020-08-21 |
| Recall number | Z-2238-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Spectrum Medical Ltd. (Z-2238-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83352/
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