Philips North America Recalls Brilliance iCT Systems Over Potential Projectile Hazard
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Philips North America Llc is recalling 47 Brilliance iCT units due to improperly torqued fasteners that could cause rotor parts to be expelled during operation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 24, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Philips North America Llc has initiated a voluntary recall of the Brilliance iCT system due to a mechanical assembly defect. Within the CT system's gantry, thirty-two (32) fasteners are used to attach the rotor to the bearing. Investigations revealed that one or more of these fasteners may not have been torqued to the required specification. If multiple fasteners fail to meet these specifications, the rotor or its components may become unsecured or displaced. This creates a risk where rotor parts could potentially be expelled during gantry rotation.
Which Products Are Affected
The recall affects 47 units of the following medical device:
- Product Name: Brilliance iCT
- Product Code (REF): 728306
- UDI-DI: 00884838059474
- Recall Number: Z-1315-2026
- Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200, 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213, 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221.
The affected units were distributed worldwide, including 24 U.S. states: AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, and WV.
What You Should Do
Philips North America Llc notified affected customers via an initial firm notification letter sent on January 7, 2026. Facilities using the Brilliance iCT system should check their serial numbers against the provided list. If your unit is affected, follow the specific guidance provided in the notification letter from Philips.
Why This Matters
While there have been no reported incidents of parts being expelled to date, the potential for unsecured rotor components to be ejected during high-speed rotation poses a significant safety hazard to both patients and medical staff.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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