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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs

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 Class 2 Device Recall Spacelabssee related information
Date Initiated by FirmOctober 29, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 17, 2004
Recall NumberZ-0269-04
Recall Event ID 27598
510(K)NumberK932724 
Product Classification Display, Cathode-Ray Tube, Medical - Product Code DXJ
ProductSpacelabs flat panel monitor, Model 91415-A
Code Information Date code range: 0001xx through 0152xx. All defective power supplies fall within the date code of week 1, 2000 and week 52, 2001. The date code can be found on the underside of the power supply, embossed at the top of the text. It will be in the format of 0108A3, which means ''01'' is the year 2001, ''08'' is week 8 and ''A3'' is the line A3.
Recalling Firm/
Manufacturer		 Datex-Ohmeda, Inc.
5150 220th AVE SE
Issaquah WA 98029
For Additional Information ContactAl VanHoudt
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
FDA Determined
Cause 2		Other
ActionA letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.
Quantity in Commerce2734 units for domestic consignees and 1099 for international consignees
DistributionThe firm distributes to hospitals nationwide. The firm also distributes internationally.
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 = DXJ
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