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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

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 Class 2 Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385see related information
Date Initiated by FirmJanuary 07, 2005
Date PostedJanuary 25, 2005
Recall Status1 Terminated 3 on January 17, 2011
Recall NumberZ-0422-05
Recall Event ID 30797
510(K)NumberK932724 
Product Classification Display, Cathode-Ray Tube, Medical - Product Code DXJ
ProductUltraview Universal Clinical Workstation System Model 90385.
Code Information Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.
Recalling Firm/
Manufacturer		 Spacelabs Medical Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information ContactAl Van Houdt
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
FDA Determined
Cause 2		Other
ActionAll US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.
Quantity in Commerce12,306 devices with this base style.
DistributionThe firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
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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