Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 4, 2019
Quantum Pump Console
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spectrum Medical Ltd. recalled Quantum Pump Console - a critical-severity action.
Quantum Pump Console was recalled by Spectrum Medical Ltd. in September 4, 2019. Reason: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in…. Check the official notice for the remedy. Verify recall #Z-2238-2019 with the FDA Devices before acting.
The recall
Spectrum Medical Ltd. issued this critical-severity FDA Devices recall-Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in….
- Critical
- severity level
- 108 units
- affected scope
- Class I
- classification
- September 4, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2238-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2238-2019) was formally reported on September 4, 2019, with the manufacturer initiating the action on May 29, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Spectrum Medical Ltd. is listed as the recalling firm, operating out of Gloucester, N/A. Federal records list the affected scope as 108 units (8 US, 100 OUS).
The documented reason for this recall is: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. Distribution data in the federal record shows the product reached: US distribution to NY, OH, VA, WA. International distribution to the Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
108 units (8 US, 100 OUS)
Related Recalls
6
0 from same agency
Product description
Quantum Pump Console
Reason for recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2238-2019 |
| Date reported | September 4, 2019 |
| Date initiated | May 29, 2019 |
| Recalling firm | Spectrum Medical Ltd. |
| Firm location | Gloucester, N/A |
| Affected scope | 108 units (8 US, 100 OUS) |
| Distribution | US distribution to NY, OH, VA, WA. International distribution to the Netherlands. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2238-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Quantum Pump Console. Recalled by Spectrum Medical Ltd.. Units affected: 108 units (8 US, 100 OUS).
Why was this product recalled? ▼
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2019. Severity: Critical. Recall number: Z-2238-2019.
Where was the recalled product distributed? ▼
Distribution: US distribution to NY, OH, VA, WA. International distribution to the Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2238-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported September 4, 2019.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.