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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Integrated Multiparameter: Temperature Probe Adaptor

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  Class 2 Device Recall Medical Integrated Multiparameter: Temperature Probe Adaptor see related information
Date Initiated by Firm July 02, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on June 07, 2011
Recall Number Z-2314-2008
Recall Event ID 48744
510(K)Number K972502  
Product Classification Multiparameter Monitor - Product Code DSI
Product Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA"
Code Information Lot numbers: OSC 01/07, OSC 02/07, OSC 03/07, OSC 04/07 and OSC 07/07.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Starting July 3, 2008 the firm issued a "MEDICAL DEVICE CORRECTION" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter that is being recalled. Technical Support will be available for customer questions and technical questions and to ensure each unit is upgraded. Contact Spacelabs Healthcare at 425-657-7200 ext 5970 if you have questions.
Quantity in Commerce 3,733
Distribution Nationwide and Worldwide to medical facilities.
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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