CLASS II Device recall · Reported 20 Feb 2019 · FDA Enforcement Report

Stationary Fluoroscopic X-ray System CombiDiagnost R90 recalled

Philips Medical Systems Gmbh, DMC is recalling Stationary Fluoroscopic X-ray System CombiDiagnost R90, distributed nationwide in the US. The recall was initiated on 7 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Quantity recalled146

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-0612-2019
FDA event ID: 81706
Recalling firm: Philips Medical Systems Gmbh, DMC, Hamburg, N/A
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2018
FDA classified: 12 Feb 2019
Reported: 20 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Nov 2018	Recall initiated by company
12 Feb 2019	Classified by FDA	+97 days
20 Feb 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

Product as listed by the FDA

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Nationwide Arizona California Georgia Illinois Minnesota Missouri Montana New Jersey Ohio Texas Utah Virginia

Questions about this recall

Why was it recalled?

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

Which lots are affected?

All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Where was it sold?

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 Philips Medical Systems Gmbh, DMC

All 33

Reported	Class	Recall	Company	Reason	Where
8 Sep 2021Device	CLASS II	CombiDiagnost R90 recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	CombiDiagnost PCF recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	CombiDiagnost GCF recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
31 Oct 2018Device	CLASS II	Philips DigitalDiagnost recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
29 Aug 2018Device	CLASS II	DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) recalled	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide

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