Recall – Surgical ablation system unintended laser release

Company: Ra Medical Systems, Inc.
Date of Enforcement Report: 7/15/2020
Class II

PRODUCT

DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System”. The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system.

Recall Number: Z-2497-2020

REASON

A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

RECALLING FIRM/MANUFACTURER

Ra Medical Systems, Inc. on 1/23/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

79 units

DISTRIBUTION

U.S. Nationwide and International

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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