Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Reported: September 23, 2015 Initiated: August 18, 2015 #Z-2784-2015
Product Description
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Reason for Recall
Some devices exhibit backup VVI operation due to a backup reset.
Details
- Recalling Firm
- St Jude Medical Cardiac Rhythm Management Division
- Units Affected
- 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)
- Distribution
- Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Saudi Arabia, Hungary, Switzerland.
- Location
- Sylmar, CA
Frequently Asked Questions
What product was recalled? ▼
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.. Recalled by St Jude Medical Cardiac Rhythm Management Division. Units affected: 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution).
Why was this product recalled? ▼
Some devices exhibit backup VVI operation due to a backup reset.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2784-2015.
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