FDAClass IIJune 3, 2015

Brilliance CT 16 Air. Computed Tomography X-ray systems recall

Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray…

Why was Brilliance CT 16 Air. Computed Tomography X-ray systems recalled?

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

System Code #, 728246, Serial #, 3376, 3393, 3444, 3466, 3650, 4055, 5234, 5239, 5311, 5366, 5387, 5388, 5403, 5408, 5417, 5418, 5420, 5421, 5422, 5427, 5450, 5483, 5484, 5497, 5503, 5507, 5574, 5610, 5614, 5626, 5639, 5692, 5729, 5736, 5800, 5804, 5853, 5905, 5909, 5925, 5927, 5989, 5993, 6128, 6149, 6232, 6308, 6313, 6322, 6351, 6384, 6389, 6462, 6488, 6604, 30061, 50002, 50033, 50048, 50062, 50065, 50069, 50080, 50095, 50097, 50099, 50137 & 500006.

Product
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
153 units total
Distribution
Distributed in China.
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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