Ultrasound systems recalled over unexpected reboots that damage the transducer
Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.
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: Scored 2 because the record's stated consequence is damage to the transducer, with no patient harm or reported injury.
Plain-English summary
Philips EPIQ Ultrasound Systems, in the models listed in the enforcement record including REF 795200, 795201, 795231, 795232 and 795234, used in conjunction with the X5-1c transducer, are being recalled.
The record, marked retroactive, states that the ultrasound may experience an unexpected automatic reboot, resulting in damage to the transducer.
The record lists 1,721 systems running software versions 9.0, 9.01 and 9.02, with REF and UDI pairings listed in the enforcement record. Distribution was worldwide, including nationwide across the United States. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is damage to the transducer, and no injuries are reported. Facilities should follow Philips' instructions.
The recalled product
- Product
- Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
- Manufacturer
- Philips Ultrasound, LLC
- Hazard
- unexpected-reboot
- transducer-damage
- software-fault
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 (2)
- Software Version Numbers: 9.0
- 9.01
Distribution
Distributed nationwide across the United States.
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