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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite

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  Class 2 Device Recall Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite see related information
Date Initiated by Firm January 28, 2019
Create Date July 22, 2019
Recall Status1 Terminated 3 on February 24, 2022
Recall Number Z-2035-2019
Recall Event ID 83220
510(K)Number K110779  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Code Information All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Inc.
35301 Se Center St
Snoqualmie WA 98065-9216
For Additional Information Contact Technical Support
800-522-7025 Ext. 2
Manufacturer Reason
for Recall		 Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
FDA Determined
Cause 2		 Software design
Action The recalling firm began issuing customer letters on 1/28/2019 via priority service, return receipt requested, to all U.S. customers. The letter was translated, as necessary, and emailed on 2/4/2019 to the international subsidiaries and distributors. The firm identified 6 new customers (5 U.S. and 1 international) and the letter for the 5 new U.S. customers was issued 5/30/2019 via priority service, return receipt requested. The letter for the 1 new international customer was emailed on 5/28/2019.
Quantity in Commerce 295 customer sites have the affected software versions
Distribution Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.
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 = DQK and Original Applicant = SPACELABS HEALTHCARE
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