Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-2233-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

Product Classification:

Class II

Date Initiated: April 24, 2024

Date Posted: July 10, 2024

Recall Number: Z-2233-2024

Event ID: 94711

Reason for Recall:

A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits

Status: Ongoing

Product Quantity: 227 units

Code Information:

UDI-DI: N/A Serial numbers: BZ-0000004 BZ-0000005 BZ-0000007 BZ-0000008 BZ-0000009 BZ-0000010 BZ-0000015 BZ-0000019 BZ-0000022 BZ-0000030 BZ-0000031 BZ-0000034 BZ-0000035 BZ-0000039 BZ-0000040 BZ-0000042 BZ-0000043 BZ-0000047 BZ-0000048 BZ-0000049 BZ-0000050 BZ-0000051 BZ-0000052 BZ-0000056 BZ-0000057 BZ-0000058 BZ-0000059 BZ-0000060 BZ-0000061 BZ-0000062 BZ-0000063 BZ-0000064 BZ-0000065 BZ-0000066 BZ-0000067 BZ-0000068 BZ-0000069 BZ-0000074 BZ-0000075 BZ-0000076 BZ-0000077 BZ-0000079 BZ-0000080 BZ-0000081 BZ-0000082 BZ-0000083 BZ-0000085 BZ-0000086 BZ-0000087 BZ-0000088 BZ-0000089 BZ-0000090 BZ-0000091 BZ-0000092 BZ-0000096 BZ-0000099 BZ-0000103 BZ-0000104 BZ-0000105 BZ-0000106 BZ-0000108 BZ-0000111 BZ-0000112 BZ-0000113 BZ-0000114 BZ-0000116 BZ-0000117 BZ-0000118 BZ-0000140 BZ-0000141 BZ-0000142 BZ-200001 BZ-200005 BZ-200007 BZ-200011 BZ-200012 BZ-200013 BZ-200017 BZ-200018 BZ-200027 BZ-200028 BZ-200029 BZ-200030 BZ-200031 BZ-200032 BZ-200033 BZ-200034 BZ-200037 BZ-200038 BZ-200042 BZ-200070 BZ-200071 BZ-200132 BZ-200184 BZ-300001 BZ-300002 BZ-300003 BZ-300004 BZ-300005 BZ-300006 BZ-300008 BZ-300009 BZ-300011 BZ-300012 BZ-300013 BZ-300014 BZ-300019 BZ-300020 BZ-300025 BZ-600004 BZ-600050 BZ-600052 BZ-600053 BZ-600055 BZ-600056 BZ-600057 BZ-600060 BZ-600064 BZ-600065 BZ-600066 BZ-600067 BZ-600086 BZ-600087 BZ-600089 BZ-600090 BZ-600117 BZ-600119 BZ-600121 BZ-600146 BZ-600147 BZ-700001 FLX-200001 FLX-200003 FLX-200004 FLX-200008 FLX-200013 FLX-200014 FLX-200015 FLX-200016 FLX-200020 FLX-200021 FLX-200022 FLX-200023 FLX-200025 FLX-200026 FLX-200028 FLX-200029 FLX-200030 FLX-200032 FLX-200033 FLX-200034 FLX-200035 FLX-200037 FLX-200044 FLX-200053 FLX-200076 FLX-200078 FLX-200079 FLX-200083 FLX-200099 FLX-200105 FLX-200112 FLX-200122 FLX-200123 FLX-200126 FLX-200127 FLX-200128 FLX-200129 FLX-200137 FLX-200138 FLX-200139 FLX-200140 FLX-200142 FLX-200155 FLX-200156 FLX-200160 FLX-200172 FLX-200175 FLX-200184 FLX-200188 FLX-200191 FLX-200194 FLX-200197 FLX-200198 FLX-200205 FLX-200206 FLX-200210 FLX-200212 FLX-200213 FLX-200214 FLX-200215 BZ-0000045 BZ-0000046 BZ-0000120 BZ-0000161 BZ-200010 BZ-200064 BZ-200065 BZ-600083 BZ-600085 BZ-700002 FLX-200055 BZ-0000036 BZ-0000037 BZ-0000038 BZ-0000070 BZ-0000071 BZ-0000072 BZ-0000129 BZ-100001 BZ-100002 BZ-100003 BZ-100004 BZ-100007 BZ-100020 BZ-100022 BZ-100025 BZ-100026 BZ-100027 BZ-100028 BZ-100029 BZ-100030 FLX-300003 FLX-300005 BZ-400001 BZ-400002 FLX-300002

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated