TemporaryFDAOngoing
Can cause harm that is usually temporary.
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.
Check the device or its packaging for
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.
- Why
- Due to a manufacturing issue (inadequate weld) for patient head positioning system.
- Distributed
- U.S. Nationwide distribution in the states of CA and TX.
- Company
- QUANTUM OPS Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0076-2027 · retrieved 2 October 2026
Read the official notice