Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 26, 2014
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by train
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audi…
Invivo Corporation recalled Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a … - a moderate-severity action.
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a … was recalled by Invivo Corporation in February 26, 2014. Reason: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Informati…. Check the official notice for the remedy. Verify recall #Z-0983-2014 with the FDA Devices before acting.
The recall
Invivo Corporation issued this moderate-severity FDA Devices recall-Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Informati….
- Moderate
- severity level
- 299 units
- affected scope
- Class II
- classification
- February 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0983-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0983-2014) was formally reported on February 26, 2014, with the manufacturer initiating the action on December 4, 2013. 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 299.
The documented reason for this recall is: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
299
Related Recalls
6
3 from same agency
Product description
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
Reason for recall
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0983-2014 |
| Date reported | February 26, 2014 |
| Date initiated | December 4, 2013 |
| Recalling firm | Invivo Corporation |
| Firm location | Orlando, FL |
| Affected scope | 299 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland 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-0983-2014) 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.
Frequently Asked Questions
What product was recalled? ▼
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.. Recalled by Invivo Corporation. Units affected: 299.
Why was this product recalled? ▼
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0983-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0983-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 26, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.