Philips Spectral CT Computed Tomography Systems Recall: Software Motion Issues
Philips has recalled 370 Spectral CT computed tomography systems due to software issues that may cause unintended motion of the gantry or table, potentially resulting in contact with patients or operators.
What this means for you
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: This is a Class II medical device recall for a risk-of-harm product (unintended motion may cause contact between equipment and patients or operators). No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Philips North America LLC has recalled approximately 370 Spectral CT computed tomography X-ray systems. The systems contain software that may cause unintended motion of the imaging gantry or patient table, potentially resulting in contact with patients or operators, along with issues affecting CT system performance.
The hazard stems from software defects that produce unintended motion in the gantry and table. Healthcare facilities using affected systems should be aware of this potential risk.
The recalled systems were distributed in multiple U.S. states and to numerous countries worldwide. Distribution includes Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, and West Virginia, as well as Australia, Austria, Belgium, China, France, Germany, India, Japan, and others.
Anyone with an affected system should contact Philips North America LLC with recall number Z-2034-2025 for information and further instructions regarding this recall.
The recalled product
- Product
- Spectral CT. Computed tomography X-ray system.
- Manufacturer
- Philips North America Llc
- Hazard
- unintended-motion
- collision-risk
- software-malfunction
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)
- Part No. 728333
- UDI: (01)00884838101111(21)10014
- (01)00884838101111(21)10015
- (01)00884838101111(21)10016
- (01)00884838101111(21)10017
- (01)00884838101111(21)10018
- (01)00884838101111(21)10019
- (01)00884838101111(21)10020
- (01)00884838101111(21)10021
- (01)00884838101111(21)10022
- (01)00884838101111(21)10023
- (01)00884838101111(21)10024
- (01)00884838101111(21)10025
- (01)00884838101111(21)10027
- (01)00884838101111(21)10031
- (01)00884838101111(21)10032
- (01)00884838101111(21)10033
- (01)00884838101111(21)10034
- (01)00884838101111(21)10035
- (01)00884838101111(21)10036
Distribution
Distributed in 19 states:
- AZ
- CA
- CO
- FL
- GA
- HI
- IN
- KY
- MA
- MD
- MN
- NY
- OH
- OR
- PA
- TX
- VT
- WA
- WV
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