The Recall Desk
HighFDA (Devices)·Z-0443-2022·Announced 2022-01-05

Medical Device Aberrometer Systems Affected by Remote Code Execution Vulnerability

AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.

What this means for you

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: This is an FDA Class II medical device recall for a remote code execution vulnerability. The source text does not report any illnesses, injuries, or confirmed incidents of exploitation. Per the rubric, high-risk medical device hazards without reported injuries classify as High (3).

Plain-English summary

AMO Manufacturing USA, LLC is recalling 711 units of iDesign aberrometer and precision laser systems (Models G300 and G301) due to a remote code execution vulnerability affecting the Windows Print Spooler service. The vulnerability allows improperly performed privileged file operations on the devices.

An attacker could exploit this vulnerability to run arbitrary code with SYSTEM-level privileges. This could allow program installation, viewing or changing data, deleting data, or creation of new user accounts with full administrative rights.

The affected units have been distributed across the United States and internationally to countries including Canada, Mexico, and numerous others. These systems include Model G300 running Windows XP and Model G301 running Windows 7 Embedded System. Healthcare providers currently using these systems should contact AMO Manufacturing USA, LLC for information about remediation options.

The recalled product

Product
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Manufacturer
AMO Manufacturing USA, LLC
Category
Medical Device — Aberrometer / Laser System
Hazard
  • remote-code-execution
  • privilege-escalation

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 (1)

  • G300 with Windows XP. G301 with Windows 7 Embedded System.

Distribution

Distributed in 47 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DE
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI

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