RegWardenFDA facility compliance records
Recall

Class II — PHILIPS MEDICAL SYSTEMS

Recalling firmPhilips Medical Systems International BV
Registered facilityView this company's 54 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonWhile performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
ProductCombiDiagnost R90 1.0 (709030)
Quantity86 units
DistributionUS Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
Initiated2022-02-11
Classified2024-02-14
Recall numberZ-1087-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — PHILIPS MEDICAL SYSTEMS (Z-1087-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93819/

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