Z-1623-2023Class II

Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

Name: Z-1623-2023 Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Creator: Philips Headquarters Cambridge
Published: 2023-04-12
License: https://open.fda.gov/license/

Philips Headquarters Cambridge / initiated 2023-04-12 / Open, Classified / root cause: software

FDA source

PHILIPS HEADQUARTERS CAMBRIDGE began a recall of Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS) on 2023-04-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1623-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-12
Posted: 2023-05-23
Recalling firm: Philips Headquarters Cambridge
Product: Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root cause: Software design
Action: 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).
Quantity in commerce: 22 units
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 codes and lots: UDI-DI: (01)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1622-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23
Z-1623-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23
Z-1624-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23
Z-1625-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)