The Recall Desk
HighFDA (Devices)·Z-0556-2021·Announced 2020-12-16

Shimadzu MH-200S X-Ray System Recalled for Ceiling Arm Software Defect

Shimadzu Medical Systems is recalling 22 MH-200S X-Ray systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

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: The recall involves a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria for potential physical harm without confirmed incidents.

Plain-English summary

Shimadzu Medical Systems is recalling 22 units of the MH-200S X-Ray system with Ceiling Suspended C-arm Support. The recall is due to a problem with the control software for the ceiling arm. This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever.

The unexpected movement of the ceiling arm could result in a possible collision or harm to the patient or the system operator. The affected devices are intended for use in cardiac, neurovascular, abdominal, and peripheral angiography, as well as other radiographic and fluoroscopic procedures.

The affected units were distributed nationwide in the United States, including in Kentucky, California, Michigan, Ohio, Connecticut, New York, South Carolina, North Carolina, Indiana, Illinois, Tennessee, Louisiana, and Montana. Affected serial numbers are listed in the agency's recall record. Healthcare facilities should contact Shimadzu Medical Systems for instructions on how to address the software issue.

The recalled product

Product
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Imaging Equipment
Hazard
Affected units
22

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)

  • Affected Serial Numbers: 0161K35901
  • 0161K46901
  • 0161K58202
  • 0161K56001
  • 0161K55702
  • 0161K55301
  • 0161K55202
  • 0161K47102
  • 0161K46802
  • 0161K46301
  • 0161K36501
  • 0161K36301
  • 0161K35702
  • 0161K36202
  • 40AAE701B001
  • 0161K49301
  • 0161K48601
  • 0161K48501
  • 0161K36402
  • 0161K35602

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Shimadzu Medical Systems 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 3 products in this recall →

Related recalls

Same manufacturer · Shimadzu Medical Systems

See all →

Same hazard · collision

See all →