Z-1202-06

Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09...

Name: Z-1202-06 Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09...
Creator: Spacelabs Medical Incorporated
Published: 2006-05-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-05-05 / Terminated

FDA source

Spacelabs Medical Incorporated began a recall of Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV... on 2006-05-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1202-06
Status: Terminated
Initiated: 2006-05-05
Posted: 2006-07-06
Terminated: 2010-12-27
Recalling firm: GE Healthcare
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.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: 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.
FDA 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 service engieneer will schedule a time to visit and install the improvements.
Quantity in commerce: 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.
Product codes and lots: All systems - each major component has its own serial number

Product code DSI

K925510Class IIModel 90478 & 90479 Telemetry Rec. Module&housingSpacelabs Medical, Inc. / cleared 1994-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)