Recall Z-2150-2012 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
FMS, Finapres Medical Systems BV
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
| Date | Aug 6, 2012 (initiated Jul 6, 2012) |
| Status | Terminated |
| Reason | Battery may become hot and leak |
| Root cause | Process control |
| Action | Finapres Medical Systems BV sent a Field Safety Notice letter dated July 6, 2012 to notified US accounts of the recall. The letter identified the affected product, description of the problem and actions to be taken. The letter states that the recalling firm recommends not using the affected battery packs. A replacement battery was included in shipment. Customers were requested to return recalled battery. For questions call +31 (0)20 609 0974 or email info@finapres.com. |
| Quantity | 3 units US |
| Distribution | US Nationwide Distribution - including the states of: OH and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023338 | PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 Fms, Finapres Medical Systems BV, May 9, 2003 |