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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.
Brand
Spacelabs Medical Incorporated
Lot Codes / Batch Numbers
All systems - each major component has its own serial number
Products Sold
All systems - each major component has its own serial number
Spacelabs Medical Incorporated is recalling Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 9 due to Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of bot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 service engieneer will schedule a time to visit and install the improvements.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026