Philips Incisive CT Recall Over Bolus Tracking Scan Failure
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips Healthcare (Suzhou) Co., Ltd. is recalling certain Incisive CT devices due to potential failure to trigger clinical scans during Bolus Tracking.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Potential of failing to trigger clinical scan during Bolus Tracking.", distributed u.s. nationwide and u.s. territories distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The recall was initiated due to the potential of failing to trigger clinical scan during Bolus Tracking.
Which Products Are Affected
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. Device Identifier: (01)00884838085015, (01)00884838105508. Distributed to U.S. Nationwide and U.S. Territories. Recall number Z-2988-2026. Recall initiated June 26, 2026.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
This Class II recall affects CT imaging devices distributed across the United States and territories.
Source
https://www.fda.gov (Recall Number: Z-2988-2026, Event ID: 99511)
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (706 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.