CLASS II Device recall · Reported 22 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, Georgia, Michigan, New Jersey, Nevada, Texas. The recall was initiated on 5 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-0069-2015
- FDA event ID
- 69179
- Recalling firm
- Invivo, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2014
- FDA classified
- 15 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 5 Sep 2014 | Recall initiated by company | |
| 15 Oct 2014 | Classified by FDA | +40 days |
| 22 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
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Expression MR200 MRI Patient Monitoring System
Where it was distributed
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Questions about this recall
Why was it recalled?
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
Which lots are affected?
Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.
Where was it sold?
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
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
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | MR Coils The MR Coil is intended to be used recalled by Invivo | Invivo | Other | Nationwide |
| Device | CLASS II | Monitor for the Functional Imaging System recalled by Invivo | Invivo | Other | 17 states |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System recalled by Invivo | Invivo | Device Malfunction | FL |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System recalled by Invivo | Invivo | Labeling Errors | FL |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System The Xper Flex recalled | Invivo | Temperature Abuse | Nationwide |
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 |