Merlin PCS programmer recall
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Why was Merlin PCS programmer recalled?
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)
- Product
- Merlin PCS programmer (Model # 3650), Software (Model # 3330)
- Recalling firm
- St Jude Medical Inc.
- Quantity
- 71651
- Distribution
- U.S. Nationwide distribution
- Recall date
- July 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)