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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DSI
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