S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Check against the official notice below — it lists the full affected range.
Stryker Corporation recalled 21 units of its S3 MedSurg Bed (Model 3002) because the devices were distributed to residential customers for use in home environments, when they are intended only for use in healthcare facilities such as hospitals. Although the product's labeling correctly identifies the intended healthcare facility use environment, home users may not be aware of or fully understand the instructions that were written for healthcare professionals.
The recalled beds were distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The specific serial numbers of the affected units and the device UDI are identified in the recall notice. The recall record does not specify what remedy 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: 21 units Lot/code info: Serial Numbers: 110715076 110915596 110915597 111015378 111015411 110515348 110515556 110517101 110915707 110915708 110915743 111118747 111215214 111216659 111216660 111216671 110717082 110717084 140915228 150615371 100215401 UDI: 07613327278408
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.