The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2306-2016·Announced 2016-08-10

Philips UroDiagnost x-ray system recalled due to potential bolt failure

Philips is recalling UroDiagnost x-ray systems because bolts may break, causing the c-arm to move and sag.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could cause the equipment to sag or move, posing a risk of harm, but no injuries or illnesses are reported in the source text.

Plain-English summary

Philips Electronics North America Corporation is recalling the UroDiagnost x-ray system (Product Code: 708033). The recall involves 993 units distributed worldwide, including the United States, Canada, and numerous other countries.

The recall is due to a defect where the two bolts that attach the clamping plate to the lateral shaft may break. If this occurs, the c-arm could move laterally forward, slide out of its bearings, and sag. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and users of these systems should contact Philips Electronics North America Corporation for instructions on how to address the defect. The recall is classified as Class II by the FDA.

The recalled product

Product
UroDiagnost; x-ray system. Product Code: 708033
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — X-ray System
Hazard
Affected units
993

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • All serial numbers. 708033 System serial numbers 1
  • 17
  • 15
  • 4
  • 3
  • 7
  • 18
  • 21
  • 8
  • 13
  • 14
  • 11
  • 5
  • 16
  • 2.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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