The Recall Desk
HighFDA (Devices)·Z-1555-2024·Announced 2024-04-24

Philips Achieva 3.0TX PET-MRI Patient Support Table Installation Defect

Philips is recalling the Achieva 3.0TX PET-MRI system because the patient support table floor plate may be incorrectly installed.

What this means for you

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: FDA Class II medical device recall for structural installation defect with no reported illnesses or injuries. The identified hazard is theoretical rather than established, warranting score 3 per the rubric.

Plain-English summary

Philips North America LLC is recalling the Achieva 3.0TX for PET, Magnetic Resonance System. The patient support table floor plate may be incorrectly installed on affected units.

The system has been distributed worldwide, including throughout the United States and in over 140 countries. The FDA has classified this as a Class II recall.

Healthcare facilities and medical professionals using this equipment should contact Philips North America LLC or the FDA for information regarding this recall and any recommended actions.

The recalled product

Product
Achieva 3.0TX for PET, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging Equipment
Hazard
  • installation-defect
  • structural-defect

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 (3)

  • Model No. 781479
  • UDI-DI n/a
  • Serial No. 43102.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category