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U.S. Department of Health and Human Services

Class 2 Device Recall General Radiographic System

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 Class 2 Device Recall General Radiographic Systemsee related information
Date Initiated by FirmSeptember 30, 2004
Date PostedMay 03, 2005
Recall Status1 Terminated 3 on March 13, 2012
Recall NumberZ-0787-05
Recall Event ID 31443
510(K)NumberK880530 
Product Classification Tube Mount, X-Ray, Diagnostic - Product Code IYB
ProductVersaRad Generator
Code Information Generator S/N''s: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.
Recalling Firm/
Manufacturer		 Fischer Imaging Corporation
12300 Grant St
Denver CO 80241-3120
For Additional Information ContactTom Gibson
303-254-2525
Manufacturer Reason
for Recall		Some VersaRad Systems have a faulty weld that may result in oil leakage.
FDA Determined
Cause 2		Other
ActionCustomers were sent notification letters.
Quantity in Commerce38 units
DistributionDomestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
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 = IYB
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