Philips Spectral CT 7500 Recalled for Multiple Software Issues Affecting Functionality
Philips is recalling 197 Spectral CT 7500 computed tomography systems due to multiple software issues affecting device functionality. The devices were distributed nationwide and internationally.
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: FDA Class II recall of a high-risk medical device (CT scanner) with software issues affecting device functionality. No reported injuries or illnesses, but the device malfunction risk to patient safety justifies classification as a risk-of-harm product.
Plain-English summary
Philips North America LLC is recalling 197 units of the Spectral CT 7500 Computed Tomography X-Ray System (Software Version 5.0.0.X) due to multiple software issues that affect device functionality.
The recalled devices are identified by Model Numbers 728333 and 728340, along with specific Unique Device Identifiers (UDIs) and serial numbers detailed in the FDA recall notice.
The affected devices were distributed within the United States and internationally to 23 countries, including Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, and the United Kingdom.
Healthcare facilities and other end-users possessing affected units should refer to the official FDA recall notice (Z-0725-2024) for identification information and instructions.
The recalled product
- Product
- Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 197
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)
- Model No. 728333 and 728340
- Unique Device Identifier (UDI) (01)00884838101111(21)10148
- (01)00884838101111(21)10158
- (01)00884838101111(21)10160
- (01)00884838101111(21)10162
- (01)00884838101111(21)10163
- (01)00884838101111(21)10165
- (01)00884838101111(21)10166
- (01)00884838101111(21)10167
- (01)00884838111103(21)397002
- (01)00884838111103(21)397003
- (01)00884838111103(21)397004
- (01)00884838111103(21)397005
- (01)00884838111103(21)397006
- (01)00884838111103(21)397007
- (01)00884838111103(21)397008
- (01)00884838111103(21)397009
- (01)00884838111103(21)397010
- (01)00884838111103(21)397011
- (01)00884838111103(21)397013
Distribution
Distributed nationwide across the United States.
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