Recall Z-1202-06 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Medical Incorporated
Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.
| Date | Jul 6, 2006 (initiated May 5, 2006) |
| Status | Terminated |
| Reason | Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes. |
| Root cause | Other |
| Action | On May 5, 2006 a letter was issued to all consignees, via return receipt requested. The letter advised consignees of the issue and provided some ways to mitigate the risk. Anyone experiencing the anomaly is to document the failure and report it to the firm. A field service representative will visit each consignee to optimize the antenna system to reduce intermodulations. After determining the root cause and validating a fix, the firm issued a second letter dated August 21, 2006 to their consignees. The letter advised consignees of three issues that needed 'improvement' and stated a servic |
| Quantity | 22 telemetry systems; 1229 transmitters |
| Distribution | The systems were distributed to 22 hospitals/medical centers nationwide and to 2 Spacelabs personnel. There is no international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925510 | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING Spacelabs Medical, Inc., Oct 27, 1994 |