FDA Device recall Z-1273-2021

Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appl…

• FDA Device
• Class II
• terminated
• Published 2021-03-24

On 2021-03-24 the FDA classified a Class II recall of Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appl… by Philips Healthcare Suzhou, citing philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly dow….

Read the official FDA Device notice

Product

Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.

Reason

Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1273-2021%22

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