Biotronik Recalls Unapproved Pacemaker Programmer Software Versions
Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to the lack of US approval rather than a reported safety failure.
Plain-English summary
Biotronik, Inc. is recalling specific versions of Pacemaker Programmer software, including PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U. These software versions are approved for use with Biotronik device programmers, specifically the Renamic and ICS 3000 models. The software allows physicians to program devices to pace exclusively in the left ventricle.
The recall is being conducted because the ventricular packing left ventricular (LV) software programming versions for Biotronik CRT-P and CRT-D devices are not approved for use in the United States. The affected product part numbers are 394229, 400335, 403222, 406797, and 408849.
A total of 768 units of the software were distributed nationwide. The source text does not specify the actions consumers or healthcare providers should take in response to this recall.
The recalled product
- Product
- PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
- Manufacturer
- BIOTRONIK, Inc.
- Hazard
- Affected units
- 768
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 (5)
- Affected Product Part Numbers: 394229
- 400335
- 403222
- 406797
- 408849
Distribution
Distributed nationwide across the United States.
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