The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1176-2024·Announced 2024-02-28

Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk

Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.

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 medical device with potential for power loss and system malfunction during critical surgical procedures. No illnesses or injuries have been reported; this qualifies as a risk-of-harm product where injury has not yet been reported, per rubric criterion for Score 3.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 14 units of the Azurion 3 with Certeray generator (three models: 722221, 722222, and 722280), which is used to provide image guidance during diagnostic, interventional, and minimally invasive surgical procedures.

The recall is due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) of the Power Invertor component. If a short circuit occurs, the system's fuses will trip, cutting power to the device and causing it to become non-functional.

When the device loses power, it cannot provide the image guidance needed for surgery, potentially causing delays or cancellation of surgical procedures.

The affected units have been distributed worldwide, including in the United States (New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, and Washington) and numerous international locations. Healthcare facilities that have received these devices should contact Philips Medical Systems Nederland B.V. for instructions regarding remediation, repair, or replacement.

The recalled product

Product
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Surgical Imaging Equipment
Hazard
Affected units
14

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 (3)

  • OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66
  • SN: 91 (01)00884838099203(21)91
  • SN: 104 (01)00884838099258(21)104

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

Same hazard · short circuit

See all →

Similar recalls