United StatesWhat's being recalled
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.
Recalling firm: QUANTUM OPS Inc, Chattanooga, TN, United States.
How to identify it
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…
The hazard
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of CA and TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)