2021 Product Recalls

Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.

A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.

The firm initiated the recall by email and hand delivery on 11/13/2019. The notice explains the malfunction and risk, and provides the following information: "Advice on action to be taken by the user: Linet has developed a correction for the side rail mechanism. We will contact you to schedule a Linet or partner technician to update your affected Eleganza 5 Beds with this correction. Until your affected beds are updated, we ask that you follow the safety information as outlined in the Eleganza 5 User manual (D9U001GE5-0101, version: 11, Publication date: 2019-11 (available at your local distributor)) when operating the side rails. Section 11.1 Side rails Chapter MANIPULATION To raise siderails up: >Grab side rail by Side Rail Handle, >Pull side rail up until it latches. You will hear audible "click". If you raise the side rails to the upper position and you find the side rail is not secured and/or no audible click is heard during this operation, take the bed out of service until the bed has been updated." Contact Linet Technical Services at phone no.: 877-815-9897

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their devices.

Courage Production, LLC. Recalls Ready-to-Eat, Fully Cooked Polish Sausage Products due to Misbranding and an Undeclared Allergen

Misbranding