CT 5300 scanners recalled over six software faults affecting movement and dose
Philips Medical Systems is recalling 165 CT 5300 scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
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: Scored 3 under the risk-of-harm criterion: uncommanded gantry movement and radiation delivered from the wrong orientation are hazards, and no injuries are reported.
Plain-English summary
The Philips CT 5300, product code 728285, running software versions 5.1.0.X and 5.1.1.X, is being recalled over six identified issues.
The firm describes: unintentional continued gantry or couch movement when a specific button series is used, requiring a manual stop; a Water Equivalent Diameter value that may set itself to zero during dose-modulated helical or axial scans, which may lead to an insufficient dose setting and noisy images; a software failure in which the ECG wave file is not saved, causing cardiac offline reconstruction to fail and the user to potentially rescan the patient; a fault in which patient orientation is changed to NULL under specific random scenarios, resulting in radiation delivered from the wrong orientation or position and producing incorrect and undiagnosable images; an inconsistent preview image display that skips images during scanning; and an auto ROI fault when mouse buttons are pressed together, which prevents the system from automatically triggering the subsequent clinical scan. Philips states there is a potential safety risk from additional tracker shots and/or rescanning a patient when the clinical scan is not triggered.
The recall covers 165 units carrying UDI-DI 00884838113237, distributed in Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Virginia, and internationally. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites running the affected software versions should follow Philips' instructions.
The recalled product
- Product
- Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Category
- Medical Device — CT scanner
- Affected units
- 165
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 (20)
- Product Code (REF): 728285
- UDI-DI: 00884838113237
- Serial Numbers: 800031
- 800073
- 800070
- 35064
- 35056
- 35043
- 35029
- 800084
- 800083
- 800076
- 800063
- 800058
- 800048
- 800040
- 800039
- 800038
- 800034
- 800033
Distribution
Part of a larger recall action
This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS 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.
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