Philips Azurion 7 B12 Recalled for Unspecified Solid-State Drives
Philips is recalling Azurion 7 B12 systems because unspecified solid-state drives may cause loss of imaging functionality, blank displays, or data storage failures.
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: The recall is classified as Class II, and the source describes a risk of reduced reliability and loss of functionality (blank displays, data loss) without reporting any illnesses, injuries, or deaths.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 209 units of the Philips Azurion 7 B12 (Model Numbers 722067 and 722225). The recall is due to the potential installation of solid-state drives (SSDs) that are not specified in the Medical Device File. These non-specified SSDs may have different performance characteristics, including reduced reliability over time.
The affected devices may experience loss of imaging functionality or motorized movement, display a blank or black screen, or fail to store newly acquired images or access previously acquired images. The recall covers units distributed worldwide, including the United States and numerous international markets.
Healthcare facilities should identify affected units by checking the model and serial numbers listed in the recall notice. Users should contact Philips for instructions on replacing the non-specified solid-state drives with those specified in the Medical Device File to restore full functionality and reliability.
The recalled product
- Product
- Philips Azurion 7 B12. Model Numbers: 722067, 722225.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Imaging System
- Affected units
- 209
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)
- 1. Model Number: 722067. UDI Numbers: (01)00884838085350(21)42
- (01)00884838085350(21)173
- (01)00884838085350(21)172
- (01)00884838085350(21)109
- (01)00884838085350(21)250
- (01)00884838085350(21)114
- (01)00884838085350(21)69
- (01)00884838085350(21)214
- (01)00884838085350(21)221
- (01)00884838085350(21)81
- (01)00884838085350(21)278
- (01)00884838085350(21)131
- (01)00884838085350(21)141
- (01)00884838085350(21)26
- (01)00884838085350(21)133
- (01)00884838085350(21)128
- (01)00884838085350(21)151
- (01)00884838085350(21)68
- (01)00884838085350(21)233
- (01)00884838085350(21)255
Distribution
Distributed nationwide across the United States.
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