Recall Z-1624-2023— PHILIPS HEADQUARTERS CAMBRIDGE

Name: FDA recall Z-1624-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-12

Class II · Ongoing

Class II FDA medical device recall by PHILIPS HEADQUARTERS CAMBRIDGE, initiated 2023-04-12. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS). Reason: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required.

Recalling firm: PHILIPS HEADQUARTERS CAMBRIDGE
Classification: Class II
Status: Ongoing
Initiated: 2023-04-12
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K212441 — Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2022-04-27
K180015 — Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2018-03-20

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

Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

Reason for recall

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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