CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
Captus 4000e Thyroid Uptake Systems- Intended to be used recalled
Mirion Technologies (Capintec) is recalling Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine, distributed nationwide in the US. The recall was initiated on 27 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1069-2024
- FDA event ID
- 93824
- Recalling firm
- Mirion Technologies (Capintec), Florham Park, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Nov 2023
- FDA classified
- 9 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Nov 2023 | Recall initiated by company | |
| 9 Feb 2024 | Classified by FDA | +74 days |
| 21 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
Where it was distributed
Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM
Questions about this recall
Why was it recalled?
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
Which lots are affected?
UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535
Where was it sold?
Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mirion Technologies (Capintec)
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Captus 4000e Thyroid Uptake System recalled | Mirion Technologies (Capintec) | Device Malfunction | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake System with Well and shielding recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake System with Well recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake System recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
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