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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE HealthCare ViewPoint 6 Recalled for Incomplete Patient Medical History

Agency Publication Date: December 16, 2025
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Summary

GE HealthCare has recalled 1,221 units of its ViewPoint 6 ultrasound software, specifically versions 6.15.3 and 6.15.4. A software defect may prevent the Patient History tab from displaying a patient's complete medical records. Healthcare providers using this system should be aware that critical information could be missing when reviewing patient cases.

Risk

Doctors and clinical staff relying on this software may make medical decisions based on incomplete data, which could lead to incorrect diagnoses or improper treatment for patients. While no specific injuries have been reported, the missing data poses a risk to patient safety.

What You Should Do

  1. This recall affects GE HealthCare ViewPoint 6 ultrasound software versions 6.15.3 and 6.15.4, identified by Catalog Number H47601AA.
  2. Identify if your ultrasound imaging system is affected by checking the software version and System ID number in the software menu. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software for medical history reviews and use alternative methods to verify complete patient medical records until the software is corrected.
  4. Contact the manufacturer or your local GE HealthCare representative to arrange for a software correction or update to resolve the incomplete history issue.
  5. Call the FDA at 1-888-463-6332 if you have additional questions or need further assistance regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GE HealthCare ViewPoint 6 (Version 6.15.3)
Variants: Version 6.15.3
Model / REF:
H47601AA
Serial Numbers (808):
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
T-XQH5 RGGW
JXAK BGRN
X563 55KC
Q759 NQ3T
YUC5 E1B7
M4DN P5QT
HJU6 59Y2
PXDU YRPA
XDRU PP57
GA26 M2DT
7QZY K6XB
FH9H X5S1
HH3Y Y4W3
R4JZ 668A
8E00 EY8A
BSB4 FJDK
T-BSB4 FJDK
CR6U 0AQ1
20XB 0UAS
SKSK 3JNJ
KUT3 2W8P
7H6Q RE0Z
5KDZ 640J
1M4R 8H6R
T-KN5N NE40
KN5N NE40
576N X8R0
B8R9 HHAP
NFG0 C3GZ
R546 M5JW
T-R546 M5JW
959J 7955
UDI:
00195278753472

UDI: (01)00195278753472(10)ViewPoint6.15.3.0

Product: GE HealthCare ViewPoint 6 (Version 6.15.4)
Variants: Version 6.15.4
Model / REF:
H47601AA
Serial Numbers (413):
0YB0 MCSK
H11S KECJ
BDQ0 8B7A
ACP6 E9U6
2HD6 1CNZ
E8E2 KA1N
0A64 BXF0
HJSP 2J83
D93B J00K
MSXR PRQD
XTZN HZZZ
T-XTZN HZZZ
GARP HXEJ
JJ90 AHW6
FTXK 34Y0
6MB1 4CB4
WSUU 3B1B
X89G SQDE
KJC2 X4TY
QY6G YT31
5BZ2 5WJE
J2AF 8037
SKDB B40U
RRED Z0WM
ZR7Z NS9K
B9KW WRBU
XWP6 BCXB
TYN4 CNSR
3X5B 37QX
T-3X5B 37QX
Z03G EMFA
66U5 1C2A
9XZC ZQGD
E3CT 79RA
Z3EW WND9
T-F7RD DEWF
ZT4Y 8B0R
ZX0E SSG4
T48W 45XM
T-T48W 45XM
JAPJ UYWP
NDMG F4KT
RC62 AFP8
7GX0 XP0U
U565 TH83
G762 X178
HY37 EPMY
16FQ YP4Y
B4NP RBY6
B26E J931
UDI:
00195278753472

UDI: (01)00195278753472(10)ViewPoint6.15.4.0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98001
Status: Active
Manufacturer: GE Healthcare GmbH
Sold By: GE HealthCare
Manufactured In: Germany
Units Affected: 1221 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.