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Incisive CT Power- Whole-body computed tomography (CT)… recallZ-1624-2023 · Philips Headquarters Cambridge · initiated Apr 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Headquarters Cambridge or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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-1624-2023
Status
Open, Classified
Initiated by the company
Apr 12, 2023
Posted by the FDA
May 23, 2023
Recalling firm
Philips Headquarters Cambridge
Quantity
1 unit
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 Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

Code information (models, lots, serial numbers)

UDI-DI: (01)00884838103467 (21) Serial Number: 102342065

Other devices under the same FDA submission

1 device cleared under K212441, 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.

Other products in the same recall event

The FDA groups related products into one recall event (event 92238).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page