Abbott Recalls Merlin PCS 3650 Software Upgrade Kit Due to Anomaly
Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit because a software anomaly may cause the device to use a previously programmed shock energy level without alerting the user.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used to program implantable cardioverter-defibrillators (ICDs). The hazard involves the potential for incorrect shock energy delivery without user alert, which poses a significant risk of injury to patients.
Plain-English summary
Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit (REF 3330) due to a software anomaly identified during internal testing. The Merlin PCS Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude Medical implantable devices and leads.
The software anomaly occurs when a non-applicable shock energy value is selected. In this scenario, the device continues to use the previously programmed energy level, and the user is not alerted that the selected value was not retained. The recall involves Software Version 24.6.1 installed into 4,733 programmers.
The affected products were distributed in the United States to Alaska, Alabama, Arkansas, Arizona, California, Colorado, the District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The firm stated there are no overseas consignees associated with the affected devices. Users should contact Abbott for further instructions on how to proceed.
The recalled product
- Product
- Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
- Manufacturer
- Abbott
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 (2)
- Software Version: 24.6.1 Model: 3650
- GTIN: 05414734500661 Model: 3330
Distribution
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