The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0297-2027·Announced 2026-11-04

Philips Azurion 7 B20 Recalled for Unspecified Solid-State Drive Reliability Issues

Philips is recalling 457 Azurion 7 B20 systems because unspecified solid-state drives may cause loss of imaging functionality, blank displays, or inability to store or access images.

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 involves a Class II medical device where the hazard is reduced reliability leading to loss of functionality or data access, but the source does not report any illnesses, injuries, or deaths.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 457 units of the Philips Azurion 7 B20 (Model Numbers 722068 and 722226). 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 source states that these reliability issues may result in the loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images. The affected units were distributed worldwide, including in the United States and numerous other countries.

The source does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall, nor does it report any illnesses, injuries, or deaths associated with this issue.

The recalled product

Product
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging System
Hazard
Affected units
457

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: 722068. UDI Numbers: (01)00884838085367(21)178
  • (01)00884838085367(21)147
  • (01)00884838085367(21)205
  • (01)00884838085367(21)170
  • (01)00884838085367(21)494
  • (01)00884838085367(21)247
  • (01)00884838085367(21)149
  • (01)00884838085367(21)153
  • (01)00884838085367(21)85
  • (01)00884838085367(21)320
  • (01)00884838085367(21)89
  • (01)00884838085367(21)172
  • (01)00884838085367(21)505
  • (01)00884838085367(21)271
  • (01)00884838085367(21)443
  • (01)00884838085367(21)354
  • (01)00884838085367(21)196
  • (01)00884838085367(21)73
  • (01)00884838085367(21)285
  • (01)00884838085367(21)406

Distribution

Distributed nationwide across the United States.

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