Recall record at a glance
| Official record | Z-1069-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Mirion Technologies (Capintec), Inc. |
| Report date | Feb 21, 2024 |
| Recall initiation date | Nov 27, 2023 |
| Quantity | 467 units |
| Location | Florham Park, NJ, United States |
Official product description
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
Why the product was 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
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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