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U.S. Department of Health and Human Services

Class 2 Device Recall Programmable Diagnostic Computer

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  Class 2 Device Recall Programmable Diagnostic Computer see related information
Date Initiated by Firm November 23, 2021
Date Posted January 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0499-2022
Recall Event ID 89199
510(K)Number K150493  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product 1. Sensis, material # 10764561; UDI: 04056869010137
2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199
3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205

The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.
Code Information 1. Sensis- 10764561; UDI: 04056869010137; Serial Numbers: 103493, 103432, 103466 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199; Serial Numbers: 103137, 103144, 103453, 103108, 103111, 103047, 103048, 103171, 103182, 103193, 103301, 103170, 103223,, 103225, 103247, 103313, 103315, 103196, 103198, 103166, 103173, 103177, 103184, 103186, 103199, 102326, 103139, 103161, 103167, 103168, 103172, 103178, 100263, 103424, 103319, 103320, 103321, 103323, 103325, 103328, 103330, 103333, 103334, 103335, 103344, 100216, 103337, 100416, 102008, 103413, 101083, 100208, 100209, 102138, 102145, 102147, 103160, 103314, 102199, 103079, 102221, 103123, 103124, 103131, 100163, 100306, 100309, 103300, 101099, 101100, 101101, 103265, 100422, 103019, 103331, 103362, 103393, 103402, 103419, 103252, 103261, 103267, 103269, 103270, 103276, 103277, 103280, 103281, 103022, 103381, 103194 103145, 103148, 103152, 100345, 102183, 103345, 103368, 103415, 103416, 103245, 103249, 103250, 103264, 103080, 103082, 103086, 103088, 103089, 103090, 100231, 103431, 103306, 103341, 103114, 100070, 100071, 100074, 102155, 102157, 103040, 103042, 103039, 102174, 102182, 103130, 103200, 103234, 103116, 103117, 103119, 103288, 103008, 103216, 103465, 103189, 103208, 102010, 102295, 102296, 102302, 100006, 100005, 103352, 103283, 103308, 103310, 103115, 103244, 103246, 103014, 103242, 102143, 103359, 103274, 103437 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205; Serial Numbers: 123021, 123004, 123047, 123053, 122011 ***Updated 1/18/22*** SENSIS Vibe Hemo, Serial #103185 ***Updated 2/24/22*** SENSIS Vibe Hemo Serial #103290 103510 103451 103461 103444 103450 103448 103445 103442 103449 103439 103457 SENSIS Vibe Combo Serial #123055 123056 123058 The following serial numbers have been removed from the scope of this recall: SENSIS Vibe Hemo Serial #103301 103424 ***Updated 8/5/22*** The following serial numbers have been added to the recall: SENSIS Vibe Combo Serial numbers 103307, 103312
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6478
Manufacturer Reason
for Recall		 Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
FDA Determined
Cause 2		 Software design
Action On November 23, 2021, Siemens Healthineers issued an Urgent Medical Device Correction notice to all users of Sensis Vibe Hemo systems, Sensis and Sensis Vibe Combo systems with software version VD12A. Please make sure that an alternative system can be used to provide treatment. Please notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX077/21/S. Siemens service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact Siemens service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 1047
Distribution US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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