FDA Medical Device Recalls (openFDA)
Medstone International Inc: STS-T Mobile x-ray system used with the STS-T lithotripter.
- Recall number
- Z-0884-04
- Recalling firm
- Medstone International Inc
- Product
- STS-T Mobile x-ray system used with the STS-T lithotripter.
- Status
- Terminated
- Initiated
- 2004-06-11
- Posted
- 2004-08-28
- Terminated
- 2004-09-01
- Reason
- 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.
- Root cause
- Other
- Action
- Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.
- Quantity
- 30 unites
- Distribution
- Nationwide
- Lot, serial or model codes
- Model STS-T
- 510(k) numbers
- not on file
- PMA numbers
- ["P870015"]
- Product code
- not on file
- Firm FEI
- 2082981
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28