CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report

Philips MR Systems: Asset 5T, Apollo 5T, Infinion 5T recalled

Philips Medical Systems (Cleveland) is recalling Philips MR Systems: Asset 5T, Apollo 5T, Infinion 5T, Eclipse/Polaris 5T, Panorama 6T 0T, distributed nationwide in the US. The recall was initiated on 7 Aug 2013 and the FDA has classified it as Class II.

Check your package

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

Quantity recalledTotal 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)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0033-2014
FDA event ID: 66312
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 7 Aug 2013
FDA classified: 21 Oct 2013
Reported: 30 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Aug 2013	Recall initiated by company
21 Oct 2013	Classified by FDA	+75 days
30 Oct 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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 clinical/radiologic diagnostic imaging applications.

Where it was distributed

Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.

Nationwide Colorado Florida Kentucky Mississippi North Carolina New Jersey Pennsylvania Puerto Rico Texas

Questions about this recall

Is Philips MR Systems: Asset 5T, Apollo 5T, Infinion 5T, Eclipse/Polaris 5T, Panorama 6T 0T recalled?

Yes. Philips Medical Systems (Cleveland) recalled Philips MR Systems: Asset 5T, Apollo 5T, Infinion 5T, Eclipse/Polaris 5T, Panorama 6T 0T on 7 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0033-2014.

Why was it 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.

Which lots 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.

Where was it sold?

Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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