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Class 2 Device Recall Programmable Diagnostic Computer |
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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
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Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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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
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Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact |
Meredith Adams 610-448-6478
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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