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) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.
FDA Recall Z-0076-2027 · Posted 2026-10-02
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Recalling FirmQUANTUM OPS Inc
Recall StatusOpen, Classified
Product CodeBWN
Date Initiated2026-07-24
Product Quantity266
Reason for Recall
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
Firm 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 (Attachment A) and return to [email protected] or [email protected]
4. If the device passes, it is suitable to continue clinical use. It will be scheduled for exchange with an upgraded unit.
a. Upon completing the Acknowledgement and Receipt Form (Attachment A), contact Enovis Customer Service at 800-520-8976 or email [email protected] to schedule the exchange, or
b. Upon completing the Business Reply Form (Attachment A), Stryker will contact the account to schedule the exchange.
5. If the device fails, segregate the device and do not continue use.
a. Upon completing the Acknowledgement and Receipt Form (Attachment A), please contact Enovis Customer Service at 800-520-8976 or email [email protected] to arrange for return and issuance of replacement (upon availability), or
b. Upon completing the Business Reply Form (Attachment A), Stryker will contact your account to arrange for return and issuance of replacement (upon availability).
-The returned device will be replaced with an upgraded unit.
6. If affected product is NOT found:
a. Please complete Acknowledgement and Receipt Form (Attachment A).
8. Maintain awareness of this communication internally until all required actions have been completed within their facility. Response is required.
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide distribution in the states of CA and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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