O-Arm 1000 Imaging System (2019-05-14)

Starting date:

May 14, 2019

Posting date:

June 7, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70127

Last updated: 2019-06-07

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  Reason
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  Affected products

Affected Products

O-Arm 1000 Imaging System

Reason

Notifications initiated by manufacturer to inform the impacted consignees of the following issues:

• Failures of the charger boards:  if a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity. This can result in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced. If the system is around a patient at the time the power is lost, the gantry can still be manually opened, and the system can be moved away from the patient; however, X-ray images cannot be taken.
• MVS fuses: the O-arm 1000 imaging system is largely prevented from being susceptible to inrush current surges when being plugged in. However, when a component in the system used for inrush current surge limiting times out, and there is no longer any protection, an inrush current surge from any other source could cause a current surge in the system. This may result in the MVS fuse to open (i.e. blow), as has been reported in the field.

Manufacturer is also voluntarily performing the following actions on affected medical devices:

• Installing a new version of the user manual
• Installing a component (mobile view station (""MVS"") heatsink) as part of the new design of the ac power input circuit
• Providing a visual mitigation card for customers to attach to the image acquisition system (""IAS"") of O-arm 1000 Imaging system to serve as a visual reminder

Affected products