CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Ingenia 1.5T, magnetic resonance imaging system recalled
Philips Medical Systems is recalling Ingenia 1.5T, magnetic resonance imaging system, distributed nationwide in the US. The recall was initiated on 13 Jun 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-1865-2014
- FDA event ID
- 68588
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2014
- FDA classified
- 24 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 13 Jun 2014 | Recall initiated by company | |
| 24 Jun 2014 | Classified by FDA | +11 days |
| 2 Jul 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Ingenia 1.5T, magnetic resonance imaging system.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.
Nationwide AlabamaArizonaCaliforniaColoradoGeorgiaMaineMichiganNew YorkOhioPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Which lots are affected?
Model Number: 781396
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 68588This product is part of a recall event; the main page for the event is Ingenia 3.0T, magnetic resonance imaging system recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ingenia 3.0T, magnetic resonance imaging system recalled | Philips Medical Systems | Foreign Material | Nationwide | |
| CLASS II | Ingenia 3.0T R5, magnetic resonance imaging system recalled | Philips Medical Systems | Foreign Material | Nationwide | |
| CLASS II | Ingenia 1.5T R5, magnetic resonance imaging system recalled | Philips Medical Systems | Foreign Material | Nationwide |
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