FDA Device recall Z-0089-2014

BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box

FDA Device
Class II
terminated
Published 2013-11-06

On 2013-11-06 the FDA classified a Class II recall of BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box by Philips Medical Systems Cleveland, citing philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0089-2014
Classification	Class II
Status	terminated
Initiated	2013-09-03
Published	2013-11-06
Last updated	2026-09-13 11:53 UTC
Company	Philips Medical Systems Cleveland
Distribution	AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, WI

Product

BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.

Reason

Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.

Identifiers

code_info	The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021,… The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021, 11000082, and 11000111. Model Number: 882482 Serial Number(s): 6000002, 6000003, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000033, 6000036, 6000037, 6000038,6000040,6000041, 60000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000082, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 600

code_info

The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021,…

The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021, 11000082, and 11000111. Model Number: 882482 Serial Number(s): 6000002, 6000003, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000033, 6000036, 6000037, 6000038,6000040,6000041, 60000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000082, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 600

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2014%22

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