Captus 4000e Thyroid Uptake SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859942006096), received between Aug 14, 2023 and Nov 30, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

3 FDA recall records name this device's identifier, 3 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 20, 2026Open, Classified

   Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

   Z-3193-2026 · Root cause: Device Design · FDA record ↗

2. Apr 22, 2024Open, Classified

   Complaints of unexpected detachment of the collimator have been reported.

   Z-1892-2024 · Root cause: Device Design · FDA record ↗

3. Nov 27, 2023Open, Classified

   Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

   Z-1069-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON 2/23/2016. THE TECHNICIAN WAS PERFORMING A THYROID UPTAKE ON PATIENT WHEN THE ARM UNEXPECTEDLY FELL TO ITS LOWEST POSITION. REVIEW BY ENGINEERING INDICATED A SPRING ARM FAILURE. NO INJURIES OCCURRED. A REPLACEMENT ASSEMBLY WAS SHIPPED AND USER INSTRUCTED TO RETURN THE DEFECTIVE PART TO MANUFACTURER FOR ENGINEERING EVALUATION AND IDENTIFICATION OF ROOT CAUSE. THE COLLIMATOR AND ARM WEIGH AND SPRING ARM ASSEMBLY WEIGH 45 POUNDS, WHICH HAS THE POTENTIAL FOR SERIOUS INJURY TO EITHER PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236365 ↗
• MalfunctionNov 22, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON APRIL 19, 2018. THE TECHNICIAN WAS PERFORMING ROUTINE QC WHEN THE SYSTEM'S ARM UNEXPECTEDLY FELL TO ITS LOWEST POSITION. REVIEW BY ENGINEERING INDICATED A SPRING ARM FAILURE. NO INJURIES OCCURRED. A REPLACEMENT ASSEMBLY WAS SHIPPED AND USER INSTRUCTED TO RETURN THE DEFECTIVE PART TO MANUFACTURER FOR ENGINEERING EVALUATION AND IDENTIFICATION OF ROOT CAUSE. THE COLLIMATOR AND ARM WEIGH AND SPRING ARM ASSEMBLY WEIGH 45 POUNDS, WHICH HAS THE POTENTIAL FOR SERIOUS INJURY TO EITHER PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190383 ↗
• MalfunctionNov 22, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON SEPTEMBER 2015. THE TECHNICIAN WAS PERFORMING AN INSPECTION AND NOTED DAMAGED CABLE AND BROKEN STOPPING PIN. REVIEW BY ENGINEERING INDICATED A SPRING ARM FAILURE. NO INJURIES OCCURRED. A REPLACEMENT ASSEMBLY WAS SHIPPED AND USER INSTRUCTED TO RETURN THE DEFECTIVE PART TO MANUFACTURER FOR ENGINEERING EVALUATION AND IDENTIFICATION OF ROOT CAUSE. THE COLLIMATOR AND ARM WEIGH AND SPRING ARM ASSEMBLY WEIGH 45 POUNDS, WHICH HAS THE POTENTIAL FOR SERIOUS INJURY TO EITHER PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190382 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  CAPTUS 4000E THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED TO RAPP-ISO GMBH, GERMANY IN AUGUST 2020. ON JUNE 24, 2023 THE TECHNICIAN ATTEMPTED TO OPERATE THE CAPTUS 4000E TO MEASURE A PHANTOM. THE PROBE UNEXPECTEDLY DISLODGED FROM THE CARRIAGE ARM. THE ARM'S ARTICULATION HAD BECOME LOOSE AND EVENTUALLY DETACHED. PRIOR TO THIS EVENT, THE SYSTEM HAD BEEN FUNCTIONING PROPERLY. USER REPORTED NO INJURY. THE COLLIMATOR ASSEMBLY WEIGHS 28 POUNDS, AND THERE IS THE POTENTIAL FOR SERIOUS INJURY IF THE COLLIMATOR WERE TO FALL AND COME INTO CONTACT WITH A PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539463 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON APRIL 2016. THE TECHNICIAN WAS PERFORMING ROUTINE CALIBRATION WHEN THE SPRING ARM FELL AND HIT THE TECHNICIAN'S LEG, CAUSING A BRUISE. NO MEDICAL TREATMENT WAS REQUIRED. DISCUSSION WITH USER INDICATES THAT THE TECHNICIAN ROUTINELY MOVED THE ARM UP AND DOWN WITHOUT RELEASING THE LOCKING MECHANISM. A REPLACEMENT ASSEMBLY WAS SHIPPED AND USER INSTRUCTED TO RETURN THE DEFECTIVE PART TO MANUFACTURER FOR ENGINEERING EVALUATION AND IDENTIFICATION OF ROOT CAUSE. THE COLLIMATOR AND ARM WEIGH AND SPRING ARM ASSEMBLY WEIGH 45 POUNDS, WHICH HAS THE POTENTIAL FOR SERIOUS INJURY TO EITHER PATIENT OR OPERATOR.

  Patient problems: Skin Discoloration

  MAUDE report 17539457 ↗