Merlin@Home Software recall
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a…
Why was Merlin@Home Software 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?
Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334
- Product
- Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a…
- Recalling firm
- St Jude Medical Inc.
- Quantity
- 495,011 units (391,093 in US)
- Distribution
- Worldwide Distribution
- Recall date
- October 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)