FDAClass IIMarch 6, 2019

Achieva 3.0T for PET recall

Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System

Why was Achieva 3.0T for PET recalled?

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

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?

All systems

Product
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
Recalling firm
Philips Medical Systems Nederlands
Quantity
11226 total
Distribution
U.S. Nationwide distribution.
Recall date
March 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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