ZERO GRAVTY HNGD SWNG ARM SYST
Received Nov 24, 2025
Report 2182318-2025-00102 · MDR key 23639314
Device
Generic name
Apron, Leaded
Manufacturer
Tidi Products LlcModel number
ZGHSACatalog number
ZGHSA
Lot number
567605-3
Product problems
- Component Incompatible
- Component Incompatible
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING PREVENTATIVE MAINTENANCE, IT WAS NOTICED BY THE TECHNICIAN, THAT THE SET SCREWS AND JAM NUTS ARE NOT TO OEM STANDARDS.
Additional Manufacturer Narrative
H3: DURING PREVENTATIVE MAINTENANCE, IT WAS NOTED BY SERVICE TECHNICIAN THAT THE SET SCREWS AND JAM NUTS ON THE UNIT DID NOT MEET OEM STANDARDS. THE UNIT WAS PREVIOUSLY PURCHASED FROM ANOTHER HOSPITAL, THOUGH THE DATE OF PURCHASE IS UNKNOWN. THE UNIT WAS ALSO RELOCATED AT SOME POINT. THIS IS AN OLDER MODEL ORIGINALLY SOLD BY CFI. TO BRING THE UNIT BACK TO OEM STANDARDS, REPLACEMENT OF THE UPPER BOOM ARM WOULD BE REQUIRED. BASED ON AVAILABLE INFORMATION, THE DEVIATION APPEARS TO BE THE RESULT OF AFTERMARKET MODIFICATIONS OR REPAIRS PERFORMED OUTSIDE OF TIDI¿S CONTROL. DEVICE EVALUATION: THE UNIT WAS NOT RETURNED FOR FORMAL EVALUATION. HOWEVER, THE REPORTED FINDINGS SUGGEST USE OF NON-ORIGINAL PARTS NOT SUPPLIED OR INSTALLED BY THE MANUFACTURER. NO INTERNAL SME INVOLVEMENT IS REQUIRED AT THIS TIME, AND THE ISSUE APPEARS RELATED TO UNAUTHORIZED ALTERATIONS RATHER THAN A MANUFACTURING DEFECT. MANUFACTURER REFERENCE FILE: (B)(4).