GlideScope Core 15-inch Monitor Recalled for Potential Image Loss Software Issue
Verathon is recalling GlideScope Core 15-inch monitors due to software issues causing potential image loss or degradation. Approximately 2,568 units were distributed across the US and internationally.
What this means for you
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: This is an FDA Class II recall for a medical device where image loss or degradation could impair clinical decision-making. No reported hospitalizations or injuries are documented in the source text, and the hazard is described as potential rather than confirmed. The score reflects a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Verathon, Inc. is recalling GlideScope Core 15-inch monitors (Model 0570-0404) due to software issues that could result in loss of image or degradation of image when the monitor is used with other connectable devices. The affected devices run software version v1.9 and earlier.
Approximately 2,568 devices have been distributed across the United States and internationally to Hong Kong, Indonesia, and Saudi Arabia. Medical professionals and facilities using these monitors should discontinue use with connectable devices until a software update is available, or contact Verathon, Inc. for further instructions.
The recalled product
- Product
- Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
- Manufacturer
- Verathon, Inc.
- Hazard
- image-loss
- image-degradation
- software-defect
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)
- Software Version: v1.9 and earlier/ UDI: UDI/DI: 00879123006639
Distribution
Distributed in 49 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
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