Recall Z-2314-2008 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Incorporated
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA"
| Date | Sep 20, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed. |
| Root cause | Nonconforming Material/Component |
| Action | Starting July 3, 2008 the firm issued a "MEDICAL DEVICE CORRECTION" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter t |
| Quantity | 3,733 |
| Distribution | Nationwide and Worldwide to medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972502 | SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 Spacelabs Medical, Inc., May 28, 1998 |