Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Summary
The FDA issued a Class II for Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Pr by Philips North America Llc. Reason: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is.
Details
Source
Device Recall
External ID
Z-3155-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Lot/Code Info: UDI: (01)00884838101111
Quantity Affected: 62
Reason for Recall
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Distribution
U.S. and U.S. Territories.
Type: FDA Mandated
Recall Initiated: 2026-08-18
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Philips North America Llc has 284 FDA actions in our database, including 284 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 284 FDA actions in our database, including 284 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3155-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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