Ultrasound reporting software recalled over incomplete patient history information
GE Healthcare is recalling 1,221 ViewPoint 6 systems because the Patient History tab in software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.
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 cites incomplete history information in a software tab with no stated consequence or reported harm.
Plain-English summary
GE HealthCare ViewPoint 6, catalog number H47601AA, a radiological image processing system, is being recalled.
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 record lists 1,221 units, covering ViewPoint 6 version 6.15.3 under UDI (01)00195278753472, with system ID numbers listed in the enforcement record. Distribution was worldwide. The FDA has classified the action as Class II.
The record describes incomplete display of history information and does not state a further consequence or report injuries. Facilities should follow GE's instructions.
The recalled product
- Product
- GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
- Manufacturer
- GE Healthcare GmbH
- Hazard
- incomplete-information
- software-fault
- patient-history
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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