Medstone International Inc STS-T Mobile x-ray system used with the STS-T lithotripter. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STS-T Mobile x-ray system used with the STS-T lithotripter.
Brand
Medstone International Inc
Lot Codes / Batch Numbers
Model STS-T
Products Sold
Model STS-T
Medstone International Inc is recalling STS-T Mobile x-ray system used with the STS-T lithotripter. due to Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for g. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026