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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare G2 Clinical Access CD

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 Class 2 Device Recall Spacelabs Healthcare G2 Clinical Access CDsee related information
Date Initiated by FirmFebruary 14, 2014
Date PostedMarch 25, 2014
Recall Status1 Terminated 3 on May 20, 2014
Recall NumberZ-1273-2014
Recall Event ID 67638
510(K)NumberK110779 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductSpacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
Code Information Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.  Serial numbers distributed in the US: "040-1565-10" and "063-1829-11".   Serial number distributed outside the US: "063-1829-11".    
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Llc
35301 Se Center St
Snoqualmie WA 98065-9216
For Additional Information Contact
425-363-5889
Manufacturer Reason
for Recall		Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.
FDA Determined
Cause 2		Labeling Change Control
ActionSpacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support. Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.
Quantity in Commerce36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
DistributionWorldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQK
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