Recall Z-0216-2007 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Welch Allyn Protocol, Inc
Propaq LT vital signs monitor, Model 802LTRN
| Date | Nov 28, 2006 (initiated Oct 22, 2006) |
| Status | Terminated |
| Reason | Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT. |
| Root cause | Other |
| Action | A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers. |
| Quantity | total of both models 1031 |
| Distribution | Devices were distributed to hospitals/medical centers and dealers worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT Welch Allyn Protocol, Inc., Mar 1, 2004 |