OrthoScan Pulse Mini C-arm 1000-0004-FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B22510000004FD0), received between Jun 6, 2019 and Jun 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K133174); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED AN ORTHOSCAN MINI C-ARM UNIT SPONTANEOUSLY ENGAGED IN FLUOROSCOPY MODE. THE ORTHOSCAN MINI C-ARM UNIT WAS PARKED IN A CORNER OF AN OCCUPIED OPERATING ROOM (OR) SUITE, PLUGGED IN TO WALL POWER, AND TURNED ON, WITH THE FOOT PEDAL MOUNTED ON THE SIDE OF THE UNIT. THE OR STAFF HEARD A FIVE-MINUTE ALARM SOUND, INDICATING THAT THE FLUOROSCOPY UNIT HAD BEEN EMITTING IONIZING RADIATION FOR FIVE MINUTES. THE OR STAFF THEN CONTACTED RADIOLOGY STAFF TO TURN UNIT OFF. PERSONNEL AND PATIENTS MAY HAVE BEEN EXPOSED TO UNNECESSARY RADIATION. AN ORTHOSCAN SERVICE ENGINEER ARRIVED AT THE FACILITY TO INVESTIGATE/REPAIR ALLEGED MALFUNCTIONING UNIT WHERE IT WAS FOUND THE SHEATH/COVERING OF THE UMBILICAL CABLE HAD A TEAR - CAUSING A SHORT AND ALLOWING THE UNIT TO ENGAGE IN FLUOROSCOPY MODE. A NEW UMBILICAL CABLE ASSEMBLY WAS INSTALLED WHICH CORRECTED THE MALFUNCTION. THE SERVICE ENGINEER DETERMINED THE FACILITY STAFF HAD BEEN USING THE UMBILICAL CABLE ASSEMBLY AS A HANDLE WHEN MANEUVERING SYSTEM AND/OR ADJUSTING C-ARM POSITION. AS A RESULT OF THE EXCESSIVE PULLING ON THE UMBILICAL CORD, THE INSULATING PROPERTIES OF THE CABLE WERE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675781 ↗
• MalfunctionJun 6, 2019Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT DURING A PROCEDURE, AN ORTHOSCAN MINI C-ARM WAS SETUP IN THE PROCEDURE ROOM AND BEFORE USE, IT ALARMED WHERE IT WAS DISCOVERED IT HAD SPONTANEOUSLY GIVEN OFF FLUOROSCOPE / X-RAY FOR A DURATION OF 5 MINUTES. PERSONNEL AND PATIENT(S) MAY HAVE BEEN EXPOSED TO UNNECESSARY RADIATION. IT DETERMINED THE FACILITY STAFF HAD BEEN USING THE UMBILICAL CABLE ASSEMBLY AS A HANDLE WHEN MANEUVERING SYSTEM AND/OR ADJUSTING C-ARM POSITION. AS A RESULT OF THE EXCESSIVE PULLING ON THE UMBILICAL CORD, THE INSULATING PROPERTIES OF THE CABLE WERE DAMAGED. NO FURTHER EVENT NOR PATIENT INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675779 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133174. One submission often covers many models, so check the product and lot details in each record.

• Z-0261-2018 · Aug 31, 2017 · Terminated
  Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical ort