RecallRadar

FDA Device recall Z-2596-2025

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246.…

On 2025-10-01 the FDA classified a Class II recall of Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246.… by Philips North America, citing the patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2596-2025
ClassificationClass II
Statusongoing
Initiated2025-08-13
Published2025-10-01
Last updated2026-09-13 11:57 UTC
CompanyPhilips North America
DistributionUS

Product

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.

Reason

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Identifiers

code_info
1. Model Number: 728240; UDI-DI: N/A; Serial Number: 6022. 2. Model Number: 728246; UDI-DI: N/A; Serial Numbers: 5029…1. Model Number: 728240; UDI-DI: N/A; Serial Number: 6022. 2. Model Number: 728246; UDI-DI: N/A; Serial Numbers: 5029, 5698, 5834, 6272, 6313, 5307, 5305, 50129, 5286, 50017, 5388, 5424, 5422, 5515, 5497, 5584, 5668, 5624, 5771, 5814, 5872, 5907, 5900, 5928, 5869, 5939, 5944, 5993, 6137, 5411, 6160, 6153, 5504, 6182, 6199, 6209, 6219, 6271, 6302, 6330, 6357, 6358, 6369, 6405, 6343, 6410, 6558, 6490, 6635, 6532, 6590, 6547, 6669, 6691, 6563, 6756, 6755, 6738, 3578, 6776, 260046, 260074, 6752, 50219, 50028, 5412, 5839. 3. Model Number: 728256; UDI-DI: N/A; Serial Numbers: 30117, 3290, 3347, 3664, 3499.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2596-2025%22

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