Z-0884-04

STS-T Mobile x-ray system used with the STS-T lithotripter

Name: Z-0884-04 STS-T Mobile x-ray system used with the STS-T lithotripter
Creator: Medstone International Inc
Published: 2004-06-11
License: https://open.fda.gov/license/

Medstone International Inc / initiated 2004-06-11 / Terminated / root cause: labeling and UDI

FDA source

Medstone International Inc began a recall of STS-T Mobile x-ray system used with the STS-T lithotripter on 2004-06-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0884-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-08-28
Terminated: 2004-09-01
Recalling firm: Medstone International Inc
Product: STS-T Mobile x-ray system used with the STS-T lithotripter.
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 30 unites
Distribution: Nationwide
Product codes and lots: Model STS-T

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)