Incisive CT Power (China)-Computed Tomography X-Ray System recallZ-2260-2023 · Philips North America · initiated Apr 25, 2023

Why it was recalled

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

FDA root cause category: Under Investigation by firm

What the company is doing

Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800798). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Recall details

Recall number

Z-2260-2023

Recall class

Class II

Status

Open, Classified

Initiated by the company

Apr 25, 2023

Posted by the FDA

Jul 28, 2023

Recalling firm

Philips North America

Quantity

53 units OUS

Product code

JAK

FDA submissions

K180015

Distribution

Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam

Product description

Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

Other devices under the same FDA submission

1 device cleared under K180015 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Incisive CT

  Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed
  13 recalls5 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92202).

• Z-2258-2023 · Open, Classified
  Incisive CT-Computed Tomography X-Ray System Model: 728143
• Z-2259-2023 · Open, Classified
  Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
• Z-2261-2023 · Open, Classified
  Incisive CT Plus-Computed Tomography X-Ray System Model: 728149