Captus 4000e Thyroid Uptake System with Well Captus 4000e Thyroid System with WellRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859942006102), received between Mar 2, 2019 and Jan 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. Apr 22, 2024Open, Classified

   Complaints of unexpected detachment of the collimator have been reported.

   Z-1893-2024 · Root cause: Device Design · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Mechanical 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 (B)(6) MEDICAL CENTER (NOW (B)(6)HEALTH) ON FEBRUARY 5, 2021. THE NUCLEAR MEDICINE TECHNICIAN WAS PERFORMING QUALITY ASSURANCE. THE COLLIMATOR UNEXPECTED DETACHED FROM THE SYSTEM ARM. PRIOR TO THIS EVENT, THE SYSTEM HAD BEEN FUNCTIONING PROPERLY. NO INJURY WAS REPORTED BY THE OPERATOR. 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 18485762 ↗
• MalfunctionJul 3, 2020Mechanical Problem; Mechanical Problem

  ON (B)(6) 2020, THE LEAD NUCLEAR MEDICINE TECHNOLOGIST FROM (B)(6) CONTACTED CAPINTEC TO REPORT THAT THE COLLIMATOR DETACHED FROM THE SPRING ARM OF THEIR CAPTUS 4000E SYSTEM, S/N (B)(4). THE COLLIMATOR ASSEMBLY WEIGHS 28 POUNDS, AND THERE IS THE POTENTIAL FOR INJURY IF THE COLLIMATOR WERE TO FALL AND COME INTO CONTACT WITH A PATIENT OR OPERATOR. THE PATIENT WAS SEATED ON A CHAIR AND THE TECHNOLOGIST WAS PREPARING TO MEASURE THE PATIENT'S THYROID. THE TECHNOLOGIST WAS ABLE TO HOLD THE COLLIMATOR TO PREVENT IT FROM FALLING. NO INJURY OCCURED TO EITHER PATIENT OR OPERATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228437 ↗
• MalfunctionOct 8, 2019Mechanical Problem; Mechanical Problem

  ON 9/19/19 END USER CONTACTED CAPINTEC TO REPORT THAT THE COLLIMATOR FELL OFF A CAPTUS 4000E SYSTEM, S/N (B)(4). USER WAS PERFORMING QC ON THE SYSTEM, AND FOUND THE COLLIMATOR DIFFICULT TO TURN. CONTINUING TO MOVE THE COLLIMATOR CAUSED IT TO FALL OFF THE ARM. THE FALL WAS BROKEN BY THE CABLE. NO INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166032 ↗
• MalfunctionMar 2, 2019Mechanical Problem; Mechanical Problem

  ON (B)(6) 2019 CAPINTEC WAS INFORMED THAT THE COLLIMATOR FELL OFF A CAPTUS 4000 THYROID UPDATE SYSTEM- SERIAL NUMBER (B)(4). TECHNOLOGIST JUST COMPLETED QC ON THE SYSTEM. SHE WAS PERFORMING CAPSULE COUNTS WHEN THE COLLIMATOR FELL OFF. NO INJURIES OCCURRED. SERVICE PERSONNEL REPLACED THE COLLIMATOR ASSEMBLY ON SITE. USER WAS INSTRUCTED TO RETURN FAILED PARTS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384799 ↗