Merlin PCS 3650 Programmer with recall
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated…
Why was Merlin PCS 3650 Programmer with recalled?
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
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 version 23.1.1
- Product
- Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated…
- Recalling firm
- St Jude Medical Inc.
- Quantity
- 10,453 units
- Distribution
- Worldwide Distribution
- Recall date
- October 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)