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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recall records

208 reported ongoing

208 records in this archive. Latest source date Jul 16, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Numbe...

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile,...

Official source
FDA device enforcement

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 72222...

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belg...

Official source
FDA device enforcement

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, J...

Official source
FDA device enforcement

Enterprise 1.5T, Model Number: 781145;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 0.5T Standard, Model Number: 781101;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.0T Omni/Stellar, Model Number: 781102;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.0T Power/Pulsar, Model Number: 781103;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T, Model Numbers: 781195 and 781295;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T Master/Nova, Model Number: 781106;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T Omni/Stellar, Model Number: 781104;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T Power/Pulsar, Model Number: 781105;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 1.5T R11, Model Number: 781170;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera 3.0T Quasar Dual, Model Number: 781150;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Intera CV, Model Number: 781107;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

SmartPath to dStream for 1.5T, Model Number: 782146;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

SmartPath to dStream for 3.0T, Model Number: 782145;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair los...

Class IIReported ongoing

Distribution: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, B...

Official source
FDA device enforcement

Allura CV20 System Code: 722031

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding ra...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belar...

Official source

Reasons in these listed records

  • Potential for temporary loss of imaging (X-ray) functionality due to software issue.
  • Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
  • A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy....
  • An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

These examples come from this result page and are not a ranking of every recall reason.

Checking PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Is there a recall on philips medical systems nederland b.v. right now?

This archive contains 208 records, including 208 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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