Recall Z-3234-2026— Philips North America Llc

Name: FDA recall Z-3234-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-08-21. It names one FDA 510(k) clearance: K052078. Product: Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;. Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052078 — ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIESPhilips Medical Systems Nederland B.V.·cleared 2005-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

Reason for recall

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Data sourced from openFDA. This site is unofficial and independent of the FDA.