Agency classClass IIOur severity:High FDA (Devices)·Z-0332-2018·Announced 2018-01-17

Philips Brilliance iCT SP CT Scanner Recall Due to Loose Screws

Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry 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 the hazard involves a structural component (screws) that may come loose, posing a risk of harm without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 134 units of the Philips Healthcare Brilliance iCT SP computed tomography x-ray system. The recall is due to a potential defect where screws holding an internal portion of the gantry, known as the Reaction Ring, to the scanner's main bearing may come loose.

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

This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Users should contact Philips Medical Systems for further instructions on how to address the issue.

The recalled product

Product: Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
loose-parts
Affected units: 134

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 SP - 728311 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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