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U.S. Department of Health and Human Services

Class 2 Device Recall Medstone STST Mobile xray system used with the STST lithotripter.

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  Class 2 Device Recall Medstone STST Mobile xray system used with the STST lithotripter. see related information
Date Initiated by Firm June 11, 2004
Date Posted August 28, 2004
Recall Status1 Terminated 3 on September 01, 2004
Recall Number Z-0884-04
Recall Event ID 29909
PMA Number P870015 
Product STS-T Mobile x-ray system used with the STS-T lithotripter.
Code Information Model STS-T
Recalling Firm/
Manufacturer		 Medstone International Inc
100 Columbia 100
Aliso Viejo CA 92656
For Additional Information Contact Ronald H. Bergeson
949-448-7700 Ext. 2203
Manufacturer Reason
for Recall		 Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required.
FDA Determined
Cause 2		 Other
Action Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.
Quantity in Commerce 30 unites
Distribution Nationwide
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.
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