CLASS II Device recall · Reported 8 Oct 2014 · FDA Enforcement Report
Philips Expression MR200 MRI Patient Monitoring System recalled
Invivo is recalling Philips Expression MR200 MRI Patient Monitoring System, distributed in California. The recall was initiated on 8 Sep 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-0001-2015
- FDA event ID
- 69192
- Recalling firm
- Invivo, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2014
- FDA classified
- 1 Oct 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 8 Sep 2014 | Recall initiated by company | |
| 1 Oct 2014 | Classified by FDA | +23 days |
| 8 Oct 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
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
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
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Where it was distributed
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Questions about this recall
Why was it recalled?
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
Which lots are affected?
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
Where was it sold?
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
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.
More recalls from Invivo
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|---|---|---|---|---|---|
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |