CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
Monitor for the Functional Imaging System recalled by Invivo
Invivo is recalling Monitor for the Functional Imaging System for Magnetic Resonance Imaging System, distributed in 17 states. The recall was initiated on 6 Feb 2020 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-1440-2020
- FDA event ID
- 84957
- Recalling firm
- Invivo, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2020
- FDA classified
- 4 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 6 Feb 2020 | Recall initiated by company | |
| 4 Mar 2020 | Classified by FDA | +27 days |
| 11 Mar 2020 | 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
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Product as listed by the FDA
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Where it was distributed
U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.
AlaskaAlabamaCaliforniaColoradoFloridaIllinoisIndianaKentuckyMassachusettsMichiganNew YorkOhioOregonPennsylvaniaTennesseeTexasWest Virginia
Questions about this recall
Why was it recalled?
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Which lots are affected?
9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Where was it sold?
U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.
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 | 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 |
| Device | CLASS II | DynaCad software consist of an MR Analysis Server software recalled | Invivo | Device Malfunction | FL |
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 |