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Recall Observatory FDA recall evidence

Device product

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013

Z-2716-2024

August 08, 2024

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 95144
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2716-2024

Official wording

Reason: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

Code information: Serial Numbers: 111 138 467 817 2928 269

Distribution pattern: Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.