Recall Z-0076-2027 ยท BWN Table And Attachments, Operating-Room
QUANTUM OPS Inc
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) p
| Date | Oct 2, 2026 (initiated Jul 24, 2026) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue (inadequate weld) for patient head positioning system. |
| Root cause | Device Design |
| Action | On 07/24 and 07/27/2026, an "URGENT: Medical Device Recall" letter was emailed to customers informing them that, the firm has received complaints describing the fracture of a welded joint below the head rest which provides support to patient s head. Customers are instructed to: 1. Inform individuals within organization who need to be aware, and pass this notice on to any organization where the product has been transferred. 2. Check internal inventory to locate the affected product. 3. Perform the device safety check as detailed in Attachment B and complete the Acknowledgement and Receipt Form |
| Quantity | 266 |
| Distribution | U.S. Nationwide distribution in the states of CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.