Incisive CT recallZ-1622-2023 · Philips Headquarters Cambridge · initiated Apr 12, 2023

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

Philips issued Urgent Medical Device Correction Letters on 4/12/23 US consignees via Certified United States Postal Service (USPS) with delivery confirmation. 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: Refer to the IFU of your Incisive CT system to ensure proper use of the Precise Position function (IFU Section 4.9). " If the patient orientation automatically selected by Precise Position (see Figure 2) is inconsistent with the preset protocol, please correct the settings as described below: o Manually select the correct orientation in the Select Patient Orientation area in the New Patient interface, or o Open the Select Patient Orientation list by clicking the patient orientation icon in the left upper corner of the series list and select the correct orientation. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " 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. 5. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a software upgrade to address the issue (reference FCO72800793). Additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Recall details

Recall number

Z-1622-2023

Status

Open, Classified

Initiated by the company

Apr 12, 2023

Posted by the FDA

May 23, 2023

Recalling firm

Philips Headquarters Cambridge

Quantity

7 units US and 76 unit OUS

Product code

JAK

FDA submissions

K212441, K180015

Distribution

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

Product description

Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Incisive CT

  Philips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed
  9 recalls20 reports

Product lines

• Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2 models · 25 reports · 16 recalls

Other devices under the same FDA submission

1 device cleared under K212441, K180015 are not named by identifier in this recall. 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 92238).

• Z-1623-2023 · Open, Classified
  Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
• Z-1624-2023 · Open, Classified
  Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
• Z-1625-2023 · Open, Classified
  Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)