Recall Z-0456-2012 ยท NZE Hyperthermia Monitor
Life Recovery Systems HD, LLC
ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature
| Date | Jan 11, 2012 (initiated Oct 21, 2011) |
| Status | Terminated |
| Reason | ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading. |
| Root cause | Process control |
| Action | Life Recovery Systems sent recall letters/return response forms dated 10/24/2011 to all consignees. Life Recovery Systems has expanded their recall to include additional units and to provide additional service to products out in the field. A new recall letter was sent to consignees on 4/27/2012. |
| Quantity | 28 units |
| Distribution | Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061023 | THERMOSUIT SYSTEM Life Recovery Systems Hd, LLC, Sep 20, 2006 |