The Recall Desk
ModerateFDA (Devices)·Z-2392-2025·Announced 2025-09-03

Philips S4-1 Lumify Transducer Probe: Labeling Clarification on Useful Life

Philips is recalling the S4-1 Lumify Transducer Probe to provide clarification and labeling that defines the useful life of ultrasound transducers. The recall affects 171,322 units distributed nationwide.

What this means for you

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: This is a Class III medical device recall focused on labeling clarification regarding useful life. No adverse events or injuries have been reported. The recall is addressed through manufacturer labeling updates.

Plain-English summary

The S4-1 Lumify Transducer Probe is an ultrasound transducer component manufactured by Philips Ultrasound, Inc., used in ultrasound imaging systems. A total of 171,322 units have been distributed throughout the United States.

Philips is recalling this device to provide clarification and labeling that defines the useful life of ultrasound transducers in the field. The manufacturer has determined that updated labeling is necessary to properly communicate the expected duration of safe and effective use of the device.

Healthcare facilities and providers currently using this device should obtain and review the revised labeling provided by Philips regarding the device's useful life. Users should follow all guidance from the manufacturer regarding proper use, maintenance, and replacement of the device in accordance with the clarified useful life information.

The recalled product

Product
S4-1 Lumify Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Ultrasound Transducer
Hazard
  • labeling-error

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.989605458222
  • 989605477101
  • 989605458221
  • UDI: (01)00884838085183(21)B3G9Q2
  • (01)00884838074231(21)B1RCZ0
  • (01)00884838074231(21)B1RD8W
  • (01)00884838074231(21)B1RDD9
  • (01)00884838074231(21)B1W89Q
  • (01)00884838074231(21)B1W8D2
  • (01)00884838085183(21)B2D2YM
  • (01)00884838074231(21)B21YB6
  • (01)00884838085183(21)B35Y6X
  • (01)00884838085183(21)B36B15
  • (01)00884838085183(21)B36B6J
  • (01)00884838086579(21)B2C7BV
  • (01)00884838085183(21)F0BH9V
  • (01)00884838085183(21)F0DDFJ
  • (01)00884838085183(21)F0DDFL
  • (01)00884838085183(21)F0DDZD
  • (01)00884838085183(21)F0DDZF

Distribution

Distributed nationwide across the United States.

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