STS-T Mobile x-ray system used with the STS-T lithotripter.
FDA device recall Z-0884-04 · posted 2004-08-28 · Terminated
Recall details
- Recalling firm
- Medstone International Inc
- 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.
- Action taken
- Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 30 unites
- Distribution
- Nationwide
- Date initiated
- 2004-06-11
- Date posted
- 2004-08-28
- Date terminated
- 2004-09-01
- Location
- Aliso Viejo, CA
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