The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0882-2026·Announced 2025-12-10

CT scanners recalled because tube heat exchanger screws may not be tightened

Philips North America is recalling 6 CT 5300 systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record states the consequence as damage to other components within the system and describes no patient harm or reported injury.

Plain-English summary

The Philips CT 5300, software versions 4.5, 5.0 and 5.1, is being recalled. The record lists model number 728285, UDI-DI 00884838113237, and serial numbers 35071, 800007, 800002, 800001, 800004 and 800003.

If the screws of the tube heat exchanger on the rotating scanner are not tightened well after being replaced, the component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged as a result of that contact.

The record lists a quantity of 6 units, outside the United States only. Distribution was worldwide, including nationwide in the United States and to a large number of other countries. The FDA has classified the action as Class II.

The stated consequence in the enforcement record is damage to other components within the system, and no injuries are reported. Facilities should follow Philips' instructions.

The recalled product

Product
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Manufacturer
Philips North America Llc
Category
Medical Device — CT scanner
Hazard
Affected units
6

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 (8)

  • 1) Model Number: 728285
  • UDI-DI: 00884838113237
  • Serial Numbers: 35071
  • 800007
  • 800002
  • 800001
  • 800004
  • 800003

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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