Class 2 Device Recall Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic

• Date Initiated by Firm: November 08, 2023
• Date Posted: January 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0771-2024
• Recall Event ID: 93567
• Product Classification: Light, surgical, ceiling mounted - Product Code FSY
• Product: Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
• Code Information: All systems affected
• Recalling Firm/ Manufacturer: Getinge Usa Sales Inc; 1 Geoffrey Way; Wayne NJ 07470-2035
• For Additional Information Contact: Jessica Minaya; 973-709-7634
• Manufacturer Reason for Recall: A potential for a light system to fall in the operating room.
• FDA Determined Cause: Equipment maintenance
• Action: An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and other replacements: Regarding: - the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws - the brake screws - the safety segments - the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued. The instruction is available on a dedicated space on the web portal https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/, and provided upon request by emailing MSA808092.sw@getinge.com Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to or-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Maquet SAS / Getinge: As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin
• Quantity in Commerce: 236793 units in total
• Distribution: US Nationwide. Global Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.