Spectrum Medical Recalls Quantum Pump Consoles Due to Shutdown Risk
Spectrum Medical Ltd. is recalling 108 Quantum Pump Consoles because they may unexpectedly shut down while in use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use."
Plain-English summary
Spectrum Medical Ltd. is recalling 108 units of the Quantum Pump Console, which is part of the Quantum Perfusion Systems. The recall involves software version 6.2.1.9 and specific serial numbers listed in the agency documentation.
The recall is being conducted because the devices have the potential to unexpectedly shut down while in use. This defect could interrupt the intended function of the perfusion system during a medical procedure.
The affected units were distributed in the United States to New York, Ohio, Virginia, and Washington, as well as internationally to the Netherlands. Users of these devices should contact Spectrum Medical Ltd. for further instructions on how to resolve the issue.
The recalled product
- Product
- Quantum Pump Console
- Manufacturer
- Spectrum Medical Ltd.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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