CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report
Medrad¿ Stellant CT Injector System with Certegra Workstation recalled
Medrad is recalling Medrad¿ Stellant CT Injector System with Certegra Workstation, distributed nationwide in the US. The recall was initiated on 20 Sep 2013 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-1686-2015
- FDA event ID
- 71296
- Recalling firm
- Medrad, Indianola, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2013
- FDA classified
- 28 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Sep 2013 | Recall initiated by company | |
| 28 May 2015 | Classified by FDA | +615 days |
| 3 Jun 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Medrad¿ Stellant CT Injector System with Certegra Workstation recalled?
Yes. Medrad recalled Medrad¿ Stellant CT Injector System with Certegra Workstation on 20 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-1686-2015.
Why was it recalled?
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
Which lots are affected?
Material numbers: 3032458, 3007301, 3010432 with serial numbers: 10054 37918 37921 36714 36721 108 40596 23834 10065 39533 20092 29884 33423 10026 10028 10032 10035 10069 29881 30351 23741 27877 10095 20693 30548 33316 21089 10123 10008 24272 37177 25989 39003 39009 38894 38894 38840 38843 34894 38833 35824 38846 26107 37073 37472 10058 10010 10076 24707 10091 38400 38403 38404 38405 40390 10093 38999 39434 37351 37359 37358 37367 40225 34619 10127 38989 37298 37461 37462 35172 35173 35175 35176 34630 25348 36811 33443 36432 38007 31538 33315 35434 20178 25804 10280 28893 31196 35454 38011 29248 30219 39034 38940 36975 23511 36937 36966 36086 10030 10027 37839 35554 33020 10212 10145 38631 31620 37996 38906 39201 38659 31537 33314 38895 39049 38930 38319 38995 38996 38678 30429 30540 10064 38322 38196 38197 39509 33230 38831 10107 37431 26933 39171 39191 34829 37684 41169
Where was it sold?
Nationwide Distribution
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.
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