CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report
Philips MR systems: Trolley Variable Height IRF recalled
Philips Medical Systems is recalling Philips MR systems: Trolley Variable Height IRF (for Ingenia 5T & 0T products), distributed nationwide in the US. The recall was initiated on 15 May 2014 and the FDA has classified it as Class II.
Check your package
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-1827-2014
- FDA event ID
- 68311
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2014
- FDA classified
- 18 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 May 2014 | Recall initiated by company | |
| 18 Jun 2014 | Classified by FDA | +34 days |
| 25 Jun 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
Product as listed by the FDA
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
Where it was distributed
Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Questions about this recall
Is Philips MR systems: Trolley Variable Height IRF (for Ingenia 5T & 0T products) recalled?
Yes. Philips Medical Systems recalled Philips MR systems: Trolley Variable Height IRF (for Ingenia 5T & 0T products) on 15 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1827-2014.
Why was it recalled?
Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
Which lots are affected?
Model Number: 9896 030 1929.1
Where was it sold?
Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
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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