Merlin PCS 3650 programmer Model 3330 software
Check against the official notice below — it lists the full affected range.
St. Jude Medical's Merlin PCS 3650 programmer Model 3330 and Merlin.net remote monitoring software have been recalled due to a potential safety issue where the software may display battery longevity predictions for certain pacemakers that are higher than actual. This problem affects approximately 29,996 programmers running software version 26.0.1 revision 1 or earlier, and the devices have been distributed throughout the United States, its territories, and numerous countries worldwide.
The recall notice does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Reason for recall: There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ. BRAZIL BULGARIA Burnei Cambodia CAMEROON Canada Chile China Colombia COTE D'IVOIRE CUBA CYPRUS CZECH Quantity: 29,996 programs Lot/code info: Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.