TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling one TruRize Clinical Chair (Model Number 3333, Serial Number 2017000300284) because the medical device was sold to a residential customer instead of being limited to healthcare facilities as intended. The chair, which is designed to position users in various seated and reclined positions, came with labeling that correctly identifies it for professional healthcare use, but a home user may not be aware of or fully understand the instructions written for healthcare professionals.
The recalled chair was distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The product's UDI (Unique Device Identifier) is 07613327322569. The source document does not specify what action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Reason for recall: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 1 unit Lot/code info: Serial Numbers: 2017000300284 UDI: 07613327322569
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.