Z-0931-2024Class I

BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131...

Name: Z-0931-2024 BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131...
Creator: Philips North America
Published: 2023-12-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-12-15 / Open, Classified / root cause: design

FDA source

Philips North America began a recall of BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161 on 2023-12-15. FDA classified it as Class I and gives the reason as "Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0931-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-15
Posted: 2024-02-02
Recalling firm: Philips North America LLC
Product: BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Root cause tag: design
FDA root cause: Component design/selection
Action: On December 15, 2023, the firm notified affected customers via URGENT Medical Device Correction letters. Customers were instructed to not position a patient's lower limbs directly under the detector below the Center of Gantry bore. Customers should circulate the notice to all users of the device for awareness and retain the letter with affected systems until the correction is complete. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit the customer site and correct the system if necessary. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). As of 3/14/24, Philips will begin inspecting all affected devices in the field to ensure alignment of the radial leadscrew. Systems that are identified as having a misaligned leadscrew will undergo a report. Additionally, Philips will begin intsallation of a secondary catching mechanism (safety plate) starting in May 2024 in all devices. The firm will contact customers to coordinate these activities.
Quantity in commerce: 106 US; 241 OUS
Distribution: Domestic distribution nationwide. International distribution worldwide.
Product codes and lots: All serial numbers are affected. No UDI-DI available for this product.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0929-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02
Z-0930-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02
Z-0931-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02

Product code KPS

K080927Class IIBrightview Vct Imaging SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2008-04-11

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)