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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Operating Room

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 Class 2 Device Recall Integrated Operating Roomsee related information
Date Initiated by FirmApril 24, 2024
Date PostedJune 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2233-2024
Recall Event ID 94711
Product Classification System, surgical, computer controlled instrument - Product Code NAY
ProductEasySuite 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.
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
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer 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
FDA Determined
Cause 2		Process control
ActionOlympus issued Urgent: Medical Device Corrective Action letter on May 24, 2024 via Courier, 2-day delivery. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to schedule an on-site service to perform the earth leakage testing on your facility s ES4K system. You may continue to use your ES4K system until an Olympus representative performs the earth leakage test. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, identify your customers, and forward them this notification. 3. Acknowledge receipt of this letter through our Olympus recall portal: a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0446 c. Complete the form as instructed and include your account ID number. 4. An Olympus representative will contact you to complete the earth leakage test which will serve as the completion of this field corrective action for your facility. Olympus requests that you report any complaints, including surgical displays becoming inoperable/unusable or touch current sensation (i.e., vibration, slight tingle), to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1.
Quantity in Commerce227 units
DistributionWorldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
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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