CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report
Captus 3000 Thyroid Uptake System Nuclear uptake probe recalled
Capintec is recalling Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by, distributed nationwide in the US. The recall was initiated on 24 Jul 2012 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-2312-2012
- FDA event ID
- 62982
- Recalling firm
- Capintec, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2012
- FDA classified
- 5 Sep 2012
- Reported
- 12 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2012 | Recall initiated by company | |
| 5 Sep 2012 | Classified by FDA | +43 days |
| 12 Sep 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
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
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
Questions about this recall
Is Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained recalled?
Yes. Capintec recalled Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained on 24 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2312-2012.
Why was it recalled?
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
Which lots are affected?
Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
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 21 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 Capintec
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Captus 4000e Thyroid Uptake System recalled by Capintec | Capintec | Other | Nationwide |
| Device | CLASS II | Captus 3000 Thyroid Uptake System recalled by Capintec | Capintec | Device Malfunction | Nationwide |
| Device | CLASS II | Captus 700 Thyroid Uptake System recalled by Capintec | Capintec | Device Malfunction | Nationwide |
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