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U.S. Department of Health and Human Services

Class 2 Device Recall ADAPTABLE Beach Chair

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 Class 2 Device Recall ADAPTABLE Beach Chairsee related information
Date Initiated by FirmJuly 24, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0076-2027
Recall Event ID 99384
Product Classification Table and attachments, operating-room - Product Code BWN
ProductBrand 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.
Code Information Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial Numbers: A-026 A-027 A-028 A-029 A-030 A-031 A-032 A-033 A-034 A-035 A-036 A-037 A-038 A-039 A-040 Lot Number: 2021120201 Serial Numbers: A-041 A-042 A-043 A-044 A-045 A-046 A-047 A-048 A-049 A-050 A-051 A-052 A-053 A-054 A-056 A-057 A-058 A-059 A-060 A-061 A-062 A-063 A-064 A-065 A-066 A-067 A-068 A-069 A-070 Lot Number: 2022010601 Serial Numbers: A-071 A-072 A-073 A-074 A-075 A-076 A-077 A-078 A-079 A-082 A-083 A-084 A-087 A-090 A-091 A-092 A-093 A-094 A-095 A-099 Lot Number: 2023012501 Serial Numbers: C-051 C-052 C-053 C-054 C-055 C-056 C-057 C-058 C-059 C-060 C-061 C-062 C-063 C-064 C-065 C-066 C-067 Lot Number: 2023020201 Serial Numbers: C-001 C-002 C-003 C-004 C-005 C-006 C-007 C-008 C-009 C-010 C-011 C-012 C-013 C-014 C-015 C-016 C-017 C-018 C-019 C-020 C-021 C-022 C-023 C-024 C-025 C-026 C-027 C-028 C-029 C-030 C-031 Lot Number: 2023060101 Serial Numbers: C-081 C-082 C-083 C-084 C-085 C-086 C-087 C-088 C-089 C-090 C-091 C-092 C-093 C-094 C-095 Lot Number: 2023071801 Serial Numbers: C-096 C-097 C-098 C-099 C-100 C-101 C-102 C-103 C-104 C-105 C-106 C-107 C-108 C-109 C-110 C-111 C-112 C-113 C-114 C-115 C-116 C-117 C-118 C-119 C-120 C-121 C-122 Lot Number: 2024081401 Serial Numbers: C-123 C-124 C-125 C-126 C-127 C-128 C-129 C-130 C-131 C-132 Lot Number: 2024091001 Serial Numbers: C-133 C-134 C-135 C-136 C-137 C-138 C-139 C-140 C-141 C-142 C-143 C-144 C-145 C-146 C-147 Lot Number: 2024100301 Serial Numbers: C-148 C-149 C-150 C-151 C-152 C-153 C-154 C-155 C-156 C-157 Lot Number: 2024110401 Serial Numbers: C-158 C-159 C-160 C-161 C-162 C-163 C-164 C-165 C-166 C-167 C-168 C-169 C-170 C-171 C-172 Product Number: 804-33-300 Lot Number: 2020102701 Serial Numbers: A-001 A-002 A-003 A-004 A-005 A-006 A-007 A-010 A-011 A-012 Lot Number: 2021050601 Serial Numbers: A-014 A-015 A-016 A-017 A-018 A-019 A-020 A-021 A-023 A-024 Lot Number: 2022031701 Serial Numbers: A-0131 A-0132 A-0133 A-0134 A-0135 A-0136 A-0138 A-0139 A-0140 Lot Number: 2023020101 Serial Numbers: C-068 C-069 C-070 C-073 C-071 C-072 C-074 C-075 C-076 C-077 C-078 C-079 C-080 Lot Number: 2023032001 Serial Numbers: C-032 C-033 C-034 C-035 C-036 C-037 C-038 C-039 C-040 C-041 C-042 C-043 C-044 C-045 C-046 C-047 C-048 C-049 C-050 2020101201. Excluded (demo/undelivered): A-008, A-009, A-013, A-022, A-025, A-0137.
FEI Number 3019856155
Recalling Firm/
Manufacturer		 QUANTUM OPS Inc
2001 N Chamberlain Ave
Chattanooga TN 37406-3808
For Additional Information ContactRamzy Alahmad
931-2008301
Manufacturer Reason
for Recall		Due to a manufacturing issue (inadequate weld) for patient head positioning system.
FDA Determined
Cause 2		Device Design
ActionOn 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 SurgicalFieldActions@enovis.com or endorecall@stryker.com 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 SurgicalFieldActions@enovis.com 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 SurgicalFieldActions@enovis.com 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.
Quantity in Commerce266
DistributionU.S. Nationwide distribution in the states of CA and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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