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U.S. Department of Health and Human Services

Class 3 Device Recall CardoMD

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 Class 3 Device Recall CardoMDsee related information
Date Initiated by FirmJune 21, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 19, 2005
Recall NumberZ-1079-04
Recall Event ID 29480
510(K)NumberK011611 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductEmission Computed Tomography System
Code Information model number 2163-3000A, 2163-3000B
FEI Number 1525965
Recalling Firm/
Manufacturer		 Adac Labs
540 Alder Dr
Milpitas CA 95035
For Additional Information ContactMuir S. Meinhold
408-321-9100
Manufacturer Reason
for Recall		Software problems may cause the detector head to drift unexpectedly
FDA Determined
Cause 2		Other
ActionNotification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)
Quantity in Commerce482 units
DistributionNationwide, all direct accounts
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 = KPS
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