Philips Ultrasound, Inc: C9-4 Transducer Probe

Recall number

Z-2363-2025

Recalling firm

Philips Ultrasound, Inc

Product

C9-4 Transducer Probe

Status

Open, Classified

Initiated

2025-07-03

Posted

2025-08-22

Terminated

not on file

Reason

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Root cause

Device Design

Action

An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.

Quantity

171,322 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

Model No. 989605365021, 989605365023, 989605387291; UDI: (01)00884838064607(21)B1FZ1B, (01)00884838064607(21)B2KL13, (01)00884838064607(21)B30GDB, (01)00884838064607(21)B33HMW, (01)00884838064607(21)B3CL5L, (01)00884838064607(21)B1VKTB, (01)00884838064607(21)B2KL31, (01)00884838064607(21)B2JZ44, (01)00884838064607(21)B3GX1T, (01)00884838064607(21)B1XRF3, (01)00884838064607(21)B34QB8, (01)00884838064607(21)B1GFMQ, (01)00884838064607(21)B1RYG9, (01)00884838064607(21)B23TC6, (01)00884838064607(21)B1XRF1, (01)00884838064607(21)B1XN5J, (01)00884838064607(21)B1RYG6, (01)00884838064607(21)B2JTTX, (01)00884838064607(21)B3DLZ0, (01)00884838064607(21)B33XZB, (01)00884838064607(21)B1NPG7, (01)00884838064607(21)B1VJYF, (01)00884838064607(21)B3H0QV, (01)00884838064607(21)B3LNZH, (01)00884838064607(21)B31DH7, (01)00884838064607(21)B1RVCQ, (01)00884838064607(21)B34VJ7, (01)00884838064607(21)B3DC5D, (01)00884838064607(21)B1RYL2, (01)00884838064607(21)B1RVCR, (01)00884838064607(21)B1RYN1, (01)00884838064607(21)B1VJYH, (01)00884838064607(21)B31DH4, (01)00884838064607(21)B1MQJ5, (01)00884838064607(21)B23T6T, (01)00884838064607(21)B1RYJP, (01)00884838064607(21)B1ZRQM, (01)00884838064607(21)B1RYMZ, (01)00884838064607(21)B1QBG1, (01)00884838064607(21)B33XZD, (01)00884838064607(21)B3BWZ4, (01)00884838064607(21)B2KL87, (01)00884838064607(21)B3DLZ3, (01)00884838064607(21)B1RT45; Serial No. B1FZ1B, B2KL13, B30GDB, B33HMW, B3CL5L, B1VKTB, B2KL31, B2JZ44, B3GX1T, B1XRF3, B34QB8, B1GFMQ, B1F22H, B1RYG9, B23TC6, B1XRF1, B1XN5J, B1CR60, B1RYG6, B2JTTX, B3DLZ0, B33XZB, B1NPG7, B1VJYF, B3H0QV, B3LNZH, B31DH7, B1RVCQ, B34VJ7, B3DC5D, B1RYL2, B1RVCR, B1RYN1, B1VJYH, B31DH4, B1MQJ5, B23T6T, 03H3VW, B1DXF7, B1RYJP, B1ZRQM, B1RYMZ, B1QBG1, 033DZ4, B33XZD, B3BWZ4, B18L6F, B2KL87, B3DLZ3, B1RT45.

510(k) numbers

["K030455","K043535"]

PMA numbers

not on file

Product code

IYN

Firm FEI

2518586

Firm city

Reedsville

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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