CLASS I Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Quantum Pump Console recalled by Spectrum Medical
Spectrum Medical is recalling Quantum Pump Console, distributed nationwide in the US. The recall was initiated on 29 May 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2238-2019
- FDA event ID
- 83352
- Recalling firm
- Spectrum Medical, Gloucester, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 May 2019
- FDA classified
- 23 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 May 2019 | Recall initiated by company | |
| 23 Aug 2019 | Classified by FDA | +86 days |
| 4 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Product as listed by the FDA
Quantum Pump Console
Where it was distributed
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Questions about this recall
Is Quantum Pump Console recalled?
Yes. Spectrum Medical recalled Quantum Pump Console on 29 May 2019. The recall is Class I and its status is Terminated. Recall number Z-2238-2019.
Why was it recalled?
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Which lots are affected?
Software version 6.2.1.9; 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, PH1000134, PH1000135, PH1000137, PH1000139, PH1000140, PH1000141, PH1000144, PH1000145, PH1000150, PH1000156, PH1000158, PH1000159, PH1000160, PH1000161, PH1000162, PH1000165, PH1000168, PH1000170, PH1000171, PH1000172, PH1000175, PH1000176, PH1000177, PH1000178, PH1000179, PH1000180, PH1000182, PH1000201, PH1000208, PH1000209, PH1000210, PH1000211, PH1000212, PH1000213, PH1000215, PH1000233, PH1000256, PH1000257, PH1000259, PH1000438, PH1000439, PH1000440, PH1000441, PH1000442, PH1000445, PH1000455, PH1000495, PH1000498, PH1000522, PH1000615, PH1000644, PH1000645, PH1000646, PH1000647, PH1000648, PH1000649, PH1000668, PH1000669, PH1000670, PH1000682, PH1000683, PH1000684, PH1000686, PH1000687, PH1000688, PH1000689, PH1000692, PH1000722, PH1000726, PH1000727, PH1000740, PH1000742, PH1000743, PH1000744, PH1000879, PH1000880, PH1000882, PH1000885, PH1000886, PH1000895, PH1000897, PH1000939, PH1000940
Where was it sold?
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spectrum Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quantum Informatics - Vision / Live Vue Monitor recalled | Spectrum Medical | Device Malfunction | 38 states |
| Device | CLASS II | Quantum Informatics - Viper Monitor, Physiological, Patient recalled | Spectrum Medical | Device Malfunction | 38 states |
| Device | CLASS II | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type recalled | Spectrum Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Quantum Perfusion Systems for CPB recalled by Spectrum Medical | Spectrum Medical | Other | Nationwide |
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