Reported Apr 1, 2020 · Terminated
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by…
Capintec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Capintec Inc · 7 Vreeland Rd · Florham Park, NJ · 07932-1511
Is this the product you have?
Captus 4000e Thyroid Uptake SystemModel Numbers 5430-30151
- and 5430-30152 - Product Usageis intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures
- Lot codes and dates
- Serial Numbers
940146940124940127940134940147940110940123940117940120940105940106940115940118940136940137940114940141940142940113940148940103940121940135940150940122940128940129940109940104940119940107940145940125940126940130940131940112940149940132940108940111940116940133940144940152940153940154940155
- Additional systems added as of 3/26/20
481 of 481 codes
940005940065940265940317940325940370940406940514940061940368940369940375940376940484940485940486940528940200940217940522940038940044940048940059940060940066940081940084940096940151940228940229940243940271940336940337940338940355940413940431940435940451940473940300940405940148940019940020940006940435940035940145940102940157940175940261940356940358940521940164
- Serial Numbers
- Amount recalled
- 48 (481 additional units added 3/26/20)
Where it was sold
- Nationwide
Why it was recalled
It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.
This product could cause temporary or reversible health problems — stop using it.
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