Reported Aug 19, 2015 · Terminated
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for…
BIOTRONIK, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BIOTRONIK, Inc. · 6024 Jean Rd · Lake Oswego, OR · 97035-5571
Is this the product you have?
- 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 namesRenamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle
- Lot codes and dates
- Affected Product Part Numbers
394229400335403222406797408849
- Affected Product Part Numbers
- Amount recalled
- 768 units (software)
Where it was sold
- Nationwide
Why it was recalled
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
This product could cause temporary or reversible health problems — stop using it.
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