The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3146-2024·Announced 2024-09-25

Medical imaging systems vulnerable to unauthorized access due to software vulnerability

GE Healthcare ViewPoint 6 medical imaging systems contain a software vulnerability (CVE-2023-43208) in Mirth Connect that could allow unauthorized access and patient data manipulation. 574 units are affected and distributed nationwide.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall of medical imaging system with a known software vulnerability (CVE-2023-43208) that could allow unauthorized access and patient data manipulation. No illnesses or injuries have been reported, but the potential for serious data compromise in a healthcare setting constitutes a risk-of-harm scenario.

Plain-English summary

GE Healthcare GmbH is recalling ViewPoint 6 radiological imaging systems due to a software vulnerability. The vulnerability exists in NexGen Healthcare Mirth Connect, versions prior to 4.4.1, and has been identified in the National Vulnerability Database as CVE-2023-43208. The vulnerability involves the potential deserialization of untrusted data.

According to the recall notice, this vulnerability could allow a malicious actor to gain unauthorized access to the ViewPoint system and potentially manipulate patient data. The recalled devices are ViewPoint 6 systems with eight model numbers: H47581RJ, H47591MA, H47591MT, H47591PE, H47591PR, H47591RA, H47591SD, and H47591YA, affecting a total of 574 units.

The affected systems were distributed nationwide across all US states and the District of Columbia. Mirth products may have been installed and configured as part of ViewPoint systems by GE HealthCare. Healthcare facilities operating affected ViewPoint 6 systems should contact GE Healthcare GmbH for guidance on addressing this security vulnerability.

The recalled product

Product
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Manufacturer
GE Healthcare GmbH
Category
Medical Device — Radiological Imaging System
Hazard
Affected units
574

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)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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