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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 05, 2006
Date Posted July 06, 2006
Recall Status1 Terminated 3 on December 27, 2010
Recall Number Z-1202-06
Recall Event ID 35391
510(K)Number K925510  
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
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.
Code Information All systems - each major component has its own serial number
Recalling Firm/
Manufacturer		 Spacelabs Medical Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Al Van Houdt
425-657-7200 Ext. 5970
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = SPACELABS MEDICAL, INC.
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