Reported Feb 21, 2024 · Ongoing

CombiDiagnost R90 1.0 (709030)

Philips Medical Systems

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PHILIPS MEDICAL SYSTEMS · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • CombiDiagnost R90 1.0 (709030)
Lot codes and dates
  • ModelR90 1.0 (709030)
  • UDI DI
    • 00884838076747
    • Software version 1.1.1 or higher
  • Serial numbers

    86 of 86 codes

    • 10000000
    • 10000002
    • 10000003
    • 10000004
    • 10000006
    • 10000011
    • 10000012
    • 10000020
    • 10000024
    • 10000027
    • 10000049
    • 10000050
    • 10000065
    • 10000066
    • 10000067
    • 10000069
    • 10000078
    • 10000081
    • 10000099
    • 10000103
    • 10000107
    • 10000140
    • 10000145
    • 10000152
    • 10000180
    • 10001001
    • 10001010
    • 10001095
    • 591362
    • SN16000009
    • SN17000003
    • SN17000007
    • SN17000015
    • SN17000022
    • SN17000111
    • SN17000114
    • SN17000118
    • SN17000120
    • SN17000121
    • SN17000122
    • SN17000123
    • SN17000128
    • SN17000129
    • SN17000130
    • SN17000145
    • SN17000146
    • SN17000147
    • SN17000148
    • SN17000153
    • SN17000157
    • SN17000163
    • SN17000165
    • SN17000166
    • SN18000003
    • SN18000004
    • SN18000010
    • SN18000021
    • SN18000025
    • SN18000033
    • SN18000037
Amount recalled
86 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

While 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips Medical Systems recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.