HIGH

Philips Ultrasound S5-2 Transducer Recall 2025 - 1 Unit Nationwide

Philips Ultrasound recalled 1 unit of the S5-2 Ultrasound Transducer sold nationwide through healthcare distributors. The recall clarifies labeling to define the useful life of the transducer in the field. Healthcare providers should stop using the device and contact Philips Ultrasound for instructions.

Quick Facts at a Glance

Recall Date
September 5, 2025
Hazard Level
HIGH
Brand
Philips Ultrasound
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

The S5-2 Ultrasound Transducer is a diagnostic imaging component used with Philips ultrasound systems to emit and receive sound waves for medical imaging.

Why This Is Dangerous

The recall focuses on clarifying labeling to define the transducer’s useful life in field use. It is not described as an immediate operational hazard but affects lifecycle management.

Industry Context

This recall is not identified as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must verify labeling and lifecycle guidance for the S5-2 transducer. The immediate action is to stop use and seek replacement or guidance according to Philips.

Practical Guidance

How to identify if yours is affected

  1. 1. Compare your transducer to Model No. 989605368393 and Serial No. B0C824.
  2. 2. Check for the presence of label or lifecycle information matching the recall.
  3. 3. If matched, stop use and contact Philips Ultrasound for instructions.
  4. 4. Follow any provided recall instructions and document actions taken.

Where to find product info

FDA enforcement page for Z-1626-2026 and Philips recall notice.

What timeline to expect

Recall does not specify a timeline for remedy. Follow manufacturer communications for next steps.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or the FDA MedWatch program.
  • Keep records of outreach attempts and local regulatory guidance.

How to prevent similar issues

  • Verify labeling for life expectancy on ultrasound transducers before deployment.
  • Maintain a tracking system for device lifecycle and recalls.
  • Choose replacement transducers from Philips that comply with current labeling guidelines.

Documentation advice

Keep the recall notice, serial/model numbers, correspondence with Philips, and any replacement instructions as part of your asset records.

Product Details

Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824. Distribution: US Nationwide. Recall date: 2025-09-05. Report date: 2026-04-01. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model No. 989605368393; Serial No. B0C824
  • Distributed nationwide in the US
  • Recall date 2025-09-05; Report date 2026-04-01
  • Remedy: Stop using; follow manufacturer instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No. 989605368393
(01)00884838064638(21)B0C824
Serial No. B0C824.
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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