FDAClass INovember 13, 2019

Forte Gamma Camera System is intended to produce images recall

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes…

Why was Forte Gamma Camera System is intended to produce images recalled?

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

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: 882290 and 882291 All systems.

Product
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
1167 in total
Distribution
Nationwide Distribution.
Recall date
November 13, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
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