Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2062-2025·Announced 2025-07-09

Philips V6-2 ultrasound transducers were refurbished beyond their useful life

Philips V6-2 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.

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: FDA Class II recall arising from refurbishment beyond the validated service life, with no clinical consequence described in the source.

Plain-English summary

The Philips V6-2 Transducer is being recalled across model numbers 989605357563, 989605415042, 989605437982, 989605387201 and 989605357561. The action covers 5,230 units.

The stated reason is that the ultrasound transducer devices were refurbished beyond their useful life. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

Distribution was nationwide in the United States and to Australia, Austria, Belgium, Brazil and other markets. The transducers are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the model numbers and UDI codes in the recall notice and follow the instructions issued by Philips Ultrasound.

The recalled product

Product: Philips V6-2 Transducer.
Manufacturer: Philips Ultrasound, Inc
Category: Medical Device — Ultrasound transducer
Hazard: refurbishment
useful-life-exceeded
class-ii
Affected units: 5,230

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. 989605357563
989605415042
989605437982
989605387201
989605357561
UDI: (01)00884838061651(21)B1F8BF
(01)00884838061798(21)036HF1
(01)00884838061651(21)B1MB1Y
(01)00884838061651(21)B1P7X7
(01)00884838061651(21)B20WDH
(01)00884838061460(21)B1CYQ2
(01)00884838061460(21)B0ZP1G
(01)00884838061460(21)B0GX06
(01)00884838061460(21)B0T41B
(01)00884838061651(21)B1RYY9
(01)00884838061651(21)B20X2D
(01)00884838061460(21)B1K7CX
(01)00884838061798(21)036GQH
(01)00884838061798(21)036QQF
(01)00884838061798(21)B0K8G6

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Philips Ultrasound, Inc 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 21 products in this recall →

Same manufacturer · Philips Ultrasound, Inc

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Same hazard · refurbishment