InvivoRecalls & reported problems across all models
Philips Ds North America LLC · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
11 open recalls name at least one Invivo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 11
We found 19 models of Invivo by Philips Ds North America LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2018 and Dec 11, 2022 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
11 FDA recall records name at least one of these models by its device identifier, 11 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Invivo recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0548-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0547-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0546-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0544-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0543-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0542-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0541-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0540-2025 · Root cause: Use error · names 3 of these models · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0539-2025 · Root cause: Use error · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0538-2025 · Root cause: Use error · names 2 of these models · Recall details · FDA record ↗
- Nov 4, 2024Open, Classified
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0537-2025 · Root cause: Use error · Recall details · FDA record ↗
Most reported Invivo problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Device Fell1
- Mechanical Jam1
- No Apparent Adverse Event1
- Thermal Decomposition of Device1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- Hematuria1
- No Clinical Signs, Symptoms or Conditions1
- Partial thickness (Second Degree) Burn1
Invivo models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Invivo 45353008930Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353028073Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353022889Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353028089Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353005457Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353022887Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353022888Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353022891Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353026479Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353028088Coil, magnetic resonance, specialty1 recall0 reports
- Invivo 45353028072Coil, magnetic resonance, specialty1 recall0 reports
- Invivo dS Breast 16ch 3.0TCoil, Magnetic Resonance, Specialty1 recall0 reports
- Invivo 459801729911Coil, magnetic resonance, specialty1 recall0 reports
- Invivo dS Breast 7ch 3.0TCoil, Magnetic Resonance, Specialty1 recall0 reports
- Invivo 101966Coil, magnetic resonance, specialty1 report
- Invivo 45980009799Coil, magnetic resonance, specialty1 report
- Invivo 98960320298INSTRUMENT, BIOPSY1 report
- Invivo 101759Coil, magnetic resonance, specialty1 report
- Invivo 459801572611System, image processing, radiological1 report
Recent Invivo adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2022No Apparent Adverse Event; No Apparent Adverse Event
SITE WOULD LIKE THE URONAV TO HAVE WI-FI CONNECTIVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15956415 ↗InjuryJul 8, 2022Use of Device Problem; Use of Device Problem
IT WAS STATED THAT A PATIENT COMPLAINED OF BURN ON ELBOW. THE EXTENT OF INJURY WAS A BLISTER, NO MEDICAL INTERVENTION WAS NEEDED. SIEMENS HEALTHCARE WAS NOTIFIED ON (B)(6) 2021. THIS COMPLAINED ISSUE IS CURRENTLY UNDER THEIR INVESTIGATION (B)(4) WHETHER OUR SYSTEM IS RELATED TO THIS COMPLAINED ISSUE. FOR FURTHER INFORMATION PLEASE CONTACT OUR MR PRODUCT RESPONSIBLE (B)(4).
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 14961363 ↗InjuryJun 24, 2020Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
TODAY (B)(6) 2020), A MRI PROSTATE BIOPSY HAD AN ADVERSE EVENT IN WHICH THE NEEDLE DID NOT RETRACT PROPERLY, RESULTING IN THE BIOPSY NEEDLE ENTERING THE BLADDER.
Patient problems: Hematuria
MAUDE report 10192567 ↗MalfunctionMar 28, 2019Thermal Decomposition of Device
KNEE COIL CAME INTO SERVICE AS A NORMAL ROUTINE REPAIR WITH NO INDICATIONS OF HEATING OR PATIENT INVOLVEMENT. DURING THE REPAIR PROCESS, INVIVO TECHNICIAN DISCOVERED THE HOUSING OF THE COIL WAS WARPED (FROM HEATING) IN AN AREA THAT WOULD BE IN CONSTANT CONTACT WITH THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8461396 ↗MalfunctionDec 10, 2018Device Dislodged or Dislocated; Device Fell
WHILE BEING SCANNED, MIRROR ASSEMBLY WAS ATTACHED TO THE MRI COIL. A SCREW HAD PREVIOUSLY FELL OUT OF THE ASSEMBLY AND DURING THE SCAN THE MIRROR DISLODGED FROM THE ASSEMBLY AND FELL TO HIT THE PATIENT'S EYE. NO MEDICAL INTERVENTION WAS NECESSARY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147940 ↗
Other Philips Ds North America LLC products
All Philips Ds North America LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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