Agency classClass IIOur severity:High FDA (Devices)·Z-1921-2020·Announced 2020-05-13

Philips Brilliance iCT Computed Tomography Systems Recalled for Bolt Defect

Philips North America, LLC is recalling 19 Brilliance iCT Computed Tomography X-Ray Systems because a bolt affixing the cooling unit to the rotor was not tightened to specification.

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 involves a structural defect in a medical device (improperly tightened bolt) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America, LLC is recalling 19 units of the Philips Brilliance iCT Computed Tomography X-Ray System, Model # 728306. The recall is due to a manufacturing defect where the bolt affixing the cooling unit to the rotor was not tightened to specification.

The affected units were distributed worldwide, including one unit distributed to Iowa. The recall covers specific serial numbers listed in the agency's structured data, including 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398, and 100117.

Healthcare facilities and consumers should contact Philips North America, LLC for instructions on how to address this defect. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product: Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Manufacturer: Philips North America, LLC
Category: Medical Device — Computed Tomography
Hazard: structural-defect
Affected units: 19

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 (18)

Serial #s 100193
100408
100457
100783
100356
100113
100380
100318
100848
100112
100742
100447
100685
100375
100449
100659
100158
100398 Additional serial number as of 5/22/20: 100117

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Philips North America, LLC 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 North America, LLC

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Same hazard · structural defect