FDA Devices recall · Reported January 21, 2015
Philips Expression MR200 MRI Patient Monitoring System.
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
Invivo Corporation recalled Philips Expression MR200 MRI Patient Monitoring System. - a moderate-severity action.
Philips Expression MR200 MRI Patient Monitoring System. was recalled by Invivo Corporation in January 21, 2015. Reason: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss …. Check the official notice for the remedy. Verify recall #Z-0958-2015 with the FDA Devices before acting.
The recall
Invivo Corporation issued this moderate-severity FDA Devices recall-The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss ….
- Moderate
- severity level
- 20 units
- affected scope
- Class II
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0958-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0958-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on October 22, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Invivo Corporation is listed as the recalling firm, operating out of Orlando, FL. Federal records list the affected scope as 20.
The documented reason for this recall is: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock. Distribution data in the federal record shows the product reached: CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Philips Expression MR200 MRI Patient Monitoring System.
Reason for recall
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0958-2015 |
| Date reported | January 21, 2015 |
| Date initiated | October 22, 2014 |
| Recalling firm | Invivo Corporation |
| Firm location | Orlando, FL |
| Affected scope | 20 |
| Distribution | CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0958-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026