Reported Aug 10, 2016 · Terminated

UroDiagnost; x-ray system. Product Code: 708033

Philips Electronics North America Corporation

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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • UroDiagnost; x-ray system
  • Product Code708033
Lot codes and dates
  • All serial numbers. 708033 System serial numbers 1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.
Amount recalled
993 total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 8, 2020 · Data as of Sep 19, 6:04 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.