[pending] GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Pending LLM rewrite. Source: FDA_DEVICE Z-0935-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
The recalled product
- Product
- GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
- Manufacturer
- GE Healthcare GmbH
- Category
- Medical Device — Devices
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 (20)
- ViewPoint 6 version 6.15.3
- UDI (01)00195278753472(10)ViewPoint6.15.3.0
- System ID numbers: F0HD Y23W
- TR41 MQHH
- MMZR D4YS
- YJJM BH20
- 02GQ KX8N
- Y13Z CK8A
- 215K QT2P
- R2RQ 6S9K
- 3SD3 XRBX
- 64TY MCQ5
- SU3C 35BJ
- FURE QR5U
- 493M 8J65
- E206 FXM2
- 0QN8 K9Z5
- 2PM0 2G22
- Y3EK ZG4H
- XM7F JE94
Distribution
Distribution scope not specified by the agency.
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