FDAClass IIOctober 30, 2013

Philips MR Systems: Asset 0.5T recall

Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for…

Why was Philips MR Systems: Asset 0.5T recalled?

There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.

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?

M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.

Product
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)
Distribution
Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
Recall date
October 30, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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