HIGH

Philips Ultrasound Systems Recalled Over Automatic Reboot Risk

Philips recalled 1,721 EPIQ Ultrasound Systems on July 14, 2022. The ultrasound may unexpectedly reboot, damaging the transducer. Healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
July 14, 2022
Hazard Level
HIGH
Brand
Philips Ultrasound
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

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, LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall involves Philips EPIQ Ultrasound Systems with model numbers 795200, 795201, 795231, 795232, 795234, 795117, and 795122. These systems were distributed worldwide, including all 50 states in the U.S. and numerous countries.

The Hazard

The ultrasound systems may experience unexpected automatic reboots. This malfunction could lead to damage to the transducer, posing a risk to operational efficiency.

Reported Incidents

There are no reported injuries associated with this recall. The malfunction primarily affects the performance of the ultrasound systems.

What to Do

Stop using the device immediately. Contact Philips Ultrasound, LLC or your healthcare provider for further instructions regarding the recall.

Contact Information

For more details, call Philips Ultrasound at 1-800-xxx-xxxx or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1007-2026.

Key Facts

  • 1,721 units recalled
  • Unexpected automatic reboot risk
  • Stop using immediately
  • Contact Philips for instructions
  • Worldwide distribution affected

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
795200
795201
795231
795232
795234
+2 more
Affected States
ALL
Report Date
January 7, 2026
Source Agency
FDA - Medical Devices
Recall Status
TERMINATED

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