LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements
GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states inaccurate measurements could lead to inappropriate clinical decisions, and no injuries are reported.
Plain-English summary
LOGIQ P9 R4.5 ultrasound systems with system software version R4.5.7, model number 5877533, are being recalled.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. The firm states this could potentially lead to inappropriate clinical decisions impacting overall care.
The recall covers 37 units carrying UDI-DI 00195278464637, with serial numbers including LP9490416, LP9490175, LP9490393, LP9490399 and LP9490376. Distribution was nationwide in the United States and global. The FDA has classified the action as Class II.
Sites running the affected software version should follow GE's instructions and treat UGAP values from that version with caution.
The recalled product
- Product
- LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 37
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 (1)
- Model 5877533 UDI-DI: 00195278464637
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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