FDAClass IIMay 11, 2016

Toshiba American Medical Systems Celesteion recall: Impurity Out of Spec

Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and…

Why was Toshiba American Medical Systems Celesteion recalled?

Potential degradation of detector performance.

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?

Serial No. 3BA1572002, 3BA1562001, 2881492002

Product
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and…
Recalling firm
Toshiba American Medical Systems Inc
Quantity
3 units
Distribution
US Distribution to WI and NV.
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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