GE HealthCare ViewPoint 6
Medical device recall Z-0935-2026. Published in FDA’s Enforcement Report on Dec 24, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 24, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 1221 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
1221 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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, 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, CCZ5 BXGJ, AXDF 5QS9, 73C8 M5NZ, GZZ6 R27Y, PT24 XDAM, EMUP X20W, 1J2C FXHS, T-1J2C FXHS, 3DUC WYDK, TG21 RSW3, 6XUS 9XCZ, M4CF 0WQ5, ERYR WQER, HKWC SUYQ, AC6A YG37, GC11 B3UG, UMXB HG5Z, T-B26E J931, 947H U85K, Q7PY 5WN5, PSUP PUC9, BEFY R4UN, 43MK TD9D, RS9S A4R2, U6BE 5BX6, 59EZ 9872, C9UY 3KDK, F9B2 8MRB, Z7X5 H282, X5G6 76RS, M32Q Z36T, A65S 86WP, CMNA RFPH, T-KA2Y 4HY3, T-YA80 ZX5C, T-8FFF PD4M, T-36Z7 UAS5, WYQ8 PCK1, T-Y9EP 31QZ, 4F2C Y3PQ, T-F8NN MB9J, HH64 GRKC, 0UWX FH6R, RJPJ R5R6, UWWH ZMHN, XXY0 AR3T, ME61 Z278, 49RT 5QXB, F6B9 CS51, 42WG 8946, CZSC DJ7B, E53Q DS7F, 1JU9 764P, 0G4S UA94, EN2K 6QM6, YDDG 0HJ1, QTR8 1F3J, 59D5 WJAS, W15C GMAH, HDAX CJKK, SZ8Z W9CZ, QNTU 134G, 8QKN 3HQ4, HMZC M3EK, PJGR 9JDD, 28NM WM72, 0HFE QU9U, 511S JXX6, TAM7 HWSE, 1T2S ZW22, PF3Z RMAG, G3NQ TWAP, JN9B 6APN, 2MDC 9MWA, 1Y1G 94YN, 4XZZ KC8B, 8HCM KAJU, XB8R QBMF, UDYP DZE4, B14H GDSJ, E9A3 269U, TTZ3 Z4UY, PNEU ZHUQ, J4EJ YB8H, 4URW UZ55, YN9U B32G, ZFBJ BQZ5, 9XW2 TE1P, 52Z8 M434, PMPB 18G7, 1RCW 57FH, KNG0 138F, D9YM 7W9K, 5CHB 7TM0, EUXC F39D, CEUC FQMM, DMSA TCBK, KYRJ HRH0, A49C 21EZ, XNAJ CJE9, 5J7X S8CK, 0AAT NXA6, T-AMSW JGDT, UW9Z UJJE, 48G5 G35J, BUB3 GCKX, 768U JTY3, 014W 0ANZ, 972P P394, C77B 383C, 00FE KG9W, QJ2A 46EU, TBE9 WHZZ, 2EQ5 NW10, 66CU 95EK, D6PA 1TQC, 4N9H UQT2, 5JS5 X6CX, GRJE RZNX, TK1J 029D, TKBK EFM3,…
FDA’s list runs to 13,870 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2025.
- FDA classified it on Dec 16, 2025.
- FDA’s Enforcement Report published it on Dec 24, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare GmbH, of Munich, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,870 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.