Gloucester, N/A, United Kingdom
Spectrum Medical Ltd. recalls
4 recalls recorded since 2018, most recently on 19 March 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 19 March 2025
- Reason
- Medical device software marketed without FDA clearance .
- Distribution
- California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentuck
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1695-2025, Z-1696-2025
- Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide nea
- Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is
Ongoing Class II Medical devices
- Recall started
- 16 January 2025
- Reason
- Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
- Distribution
- US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1327-2025
- Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Completed Class II Medical devices
- Recall started
- 13 March 2023
- Reason
- The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- Distribution
- US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0224-2025
- Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Terminated Class I Medical devices
- Recall started
- 29 May 2019
- Terminated
- 21 August 2020
- Reason
- Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
- Distribution
- US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2238-2019
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.