ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g)…
Medical device recall Z-3146-2024. Published in FDA’s Enforcement Report on Sep 25, 2024.
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 Sep 25, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 574 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?
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
574 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) H47581RJ: UDI/DI none, System ID Numbers: 4AD8 4XH3, JC82 KQTA, JZNQ HCW6, 8X0C HWWG, NURM T75T, 7R98 NQWY, AS41 ZJKE, ZU21 YYU8, E09H GGMN, DZMC NUA6, CYPQ ARE7, HJDP BKTB, TMQA Y5KK; b) H47591MA: UDI/DI (01)00840682103640(10)SP1,…
Every code shown here, 1,996 characters
a) H47581RJ: UDI/DI none, System ID Numbers: 4AD8 4XH3, JC82 KQTA, JZNQ HCW6, 8X0C HWWG, NURM T75T, 7R98 NQWY, AS41 ZJKE, ZU21 YYU8, E09H GGMN, DZMC NUA6, CYPQ ARE7, HJDP BKTB, TMQA Y5KK; b) H47591MA: UDI/DI (01)00840682103640(10)SP1, System ID Numbers: ND1G 9XAQ, Q6BJ 97G9, N8XB JU3W, UD55 W4Y3, KN5N NE40, TPF5 XNX3, 3WUB CTJ7, 113A SQPB, ZPFQ PU2B, MCH1 D8NX, Y9EP 31QZ, and UDI/DI (01)00840682103640(10)SP2, System ID Numbers: 20GN P6K5, NZHH 8S6X, F7RD DEWF, BJ4S RHT3, M6CS 194S, 0EKT TEUF, 4M7U QK91, RH1J 5CQ4; c) H47591MT: UDI/DI (01)00840682119627(10)ViewPoint6ver6.8SP1, System ID Numbers: A9PQ QW8P, HQDC YM8P, QQA4 5NMB, BGWN FEDE, QWMX 3H8H, BWXS F2FH, CZE2 JKSD, BB1Z NZ0R, N5MC 865W, ZUUT 01QZ, 6XX2 SW1N, 4F2C Y3PQ; d) H47591PE: UDI/DI (01)00840682124454(10)ViewPoint6ver6.9SP1, System ID Numbers: G00B ZJM0, 3EU2 009D, 0XP7 EJ8B, 2RUA PEXN, XNG8 X0DD, T0B8 YRFY, WGC2 8WNW, XTZN HZZZ, RJ0X 800T, BEJF WA1P, ZWM3 FRS9, 2WS7 2E10, 36SG U594, H1KX 82WQ, B8RY Z8EX, 7H6Q RE0Z, 83DP SKEE, SXD5 AGT3, ZZ68 YF5D, 6P8Z HH0D, AWM3 2FUB, ANMQ BM23, QN6D Z8PY, Q402 P0GK, WWN2 2HEU, 27F2 BP46, U3XC HZD9, FQWU 93WN, JFAH SDP2, MFUY 4K1Q, AG8N 1M16, HHGB AX1S, 1945 W95R, FC98 GMZK, MYSU ANGZ, 349X NMBE, QC0C 68Y8, E67Q QR0T, CPFN 64AA, H74D 565Z, H6SA 05SZ, KZWJ XZZ4, HH72 G643, EMHH R4B4; e) H47591PR: UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP1, System ID Numbers: AQ7G R7RP, 819A DHUF, CB3X ZXZZ, Q2GT YFTG, 947H U85K, Z7X5 H282, 5DQN S2Y0, and UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP2, System ID Numbers: TPW0 WRFA, MSXR PRQD, T2RH C58F, RGKE SE9U, 6SYX CC6K, 6MB1 4CB4, M24A 7EWH, R953 RT7G, TR41 MQHH, 02GQ KX8N, MMZR D4YS, 2UXP F2A3, 709N QMAF, SU3C 35BJ, Q9FW 4TA6, 5TE3 Y7FY, 64TY MCQ5, H3RR 9HGE, 2PM0 2G22, YJJM BH20, 493M 8J65, WF9Z SSBJ, ACP6 E9U6, XXJN UCT2, B80C XNJ7, E8E2 KA1N, Y13Z CK8A, MKY3 D2DD, 3SD3 XRBX, XX4F HS65, 2HD6 1CNZ, F4HW 726E, RDDG X11H, NX5D 2ZPA, 73GK 1DD5, JQFG 6F35, NFG0 C3GZ, FM1Z WP6J, 6832 2N28, 8C7S 4639, R269 1JA3, SUWT E2CR,…
FDA’s list runs to 7,598 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.
US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Aug 8, 2024.
- FDA classified it on Sep 13, 2024.
- FDA’s Enforcement Report published it on Sep 25, 2024.
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 7,598 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.