CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
cabinet x-ray systems intended for use recalled by Best Theratronics
Best Theratronics is recalling Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and, distributed nationwide in the US. The recall was initiated on 6 May 2016 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-2251-2016
- FDA event ID
- 74637
- Recalling firm
- Best Theratronics, KANATA, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2016
- FDA classified
- 22 Jul 2016
- Reported
- 3 Aug 2016
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 6 May 2016 | Recall initiated by company | |
| 22 Jul 2016 | Classified by FDA | +77 days |
| 3 Aug 2016 | 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
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Where it was distributed
Nationwide
Questions about this recall
Is cabinet x-ray systems intended for use in the irradiation of blood and blood products ( recalled?
Yes. Best Theratronics recalled cabinet x-ray systems intended for use in the irradiation of blood and blood products ( on 6 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2251-2016.
Why was it recalled?
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Which lots are affected?
All Raycell units with serial #'s 5000 and higher.
Where was it sold?
Nationwide
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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