Agency classClass IIOur severity:High FDA (Devices)·Z-0331-2018·Announced 2018-01-17

Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 702 units of the Philips Healthcare Brilliance iCT computed tomography x-ray system. The recall was initiated because there is a possibility that screws holding an internal portion of the gantry, known as the Reaction Ring, to the scanner's main bearing may come loose.

If this mechanical failure occurs, the affected parts will not be expelled from the device, but a noise may be heard coming from the gantry. The affected devices were manufactured between March 5, 2009, and the present. The distribution pattern includes 107 domestic accounts, 15 US Government accounts, 682 foreign accounts, 3 Mexico accounts, and 12 Canada accounts.

This recall is classified as Class II by the FDA. Healthcare facilities should contact the manufacturer for instructions on how to address this issue.

The recalled product

Product: Philips Healthcare Brilliance iCT computed tomography x-ray system
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-failure
mechanical-defect
Affected units: 702

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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