CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Spectral CT. Computed tomography X-ray system recalled
Philips North America is recalling Spectral CT. Computed tomography X-ray system, distributed in 19 states. The recall was initiated on 29 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2034-2025
- FDA event ID
- 97010
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2025
- FDA classified
- 26 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 29 May 2025 | Recall initiated by company | |
| 26 Jun 2025 | Classified by FDA | +28 days |
| 2 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Spectral CT. Computed tomography X-ray system.
Where it was distributed
Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIndianaKentuckyMassachusettsMarylandMinnesotaNew YorkOhioOregonPennsylvaniaTexasVermontWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Which lots are affected?
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, (01)00884838101111(21)10038, (01)00884838101111(21)10039, (01)00884838101111(21)10040, (01)00884838101111(21)10041, (01)00884838101111(21)10042, (01)00884838101111(21)10043, (01)00884838101111(21)10044, (01)00884838101111(21)10045, (01)00884838101111(21)10046, (01)00884838101111(21)10047, (01)00884838101111(21)10048, (01)00884838101111(21)10049, (01)00884838101111(21)10050, (01)00884838101111(21)10052, 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(01)00884838101111(21)10301, (01)00884838101111(21)12000, (01)00884838101111(21)12001, (01)00884838101111(21)12002, (01)00884838101111(21)12003, (01)00884838101111(21)12004, (01)00884838101111(21)12005, (01)00884838101111(21)12006, (01)00884838101111(21)12007, (01)00884838101111(21)12008, (01)00884838101111(21)12009, (01)00884838101111(21)396001, (01)00884838101111(21)396003, (01)00884838101111(21)396004, (01)00884838101111(21)396005, (01)00884838101111(21)396006, (01)00884838101111(21)396007, (01)00884838101111(21)396008, (01)00884838101111(21)396009, (01)00884838101111(21)396010, (01)00884838101111(21)396011; Serial No. 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10027, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042, 10043, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10052, 10053, 10055, 10056, 10057, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10074, 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Where was it sold?
Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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