Drug recall
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software…
FDA recall event 71658 · Class II · BIOTRONIK, Inc.
Key facts
| Event ID | 71658 |
|---|---|
| Recall numbers | Z-2376-2015 |
| Recalling firm | BIOTRONIK, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Jun 30, 2015 |
| Report date | Aug 19, 2015 |
| Termination date | Dec 24, 2015 |
| City | Lake Oswego |
| State | OR |
| Country | United States |
| FEI number | 1028232 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: