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Class 2 Device Recall Ysio |
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Date Initiated by Firm |
January 31, 2022 |
Create Date |
March 30, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0841-2022 |
Recall Event ID |
89703 |
510(K)Number |
K081722
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Product Classification |
System, x-ray, stationary - Product Code KPR
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Product |
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system |
Code Information |
Serial Numbers: 20113
23071
20118
22523
23021
22169
23164
22388
22119
22844
21209
23699
21114
22190
22146
22126
22128
22836
22163
22727
22135
22347
21174
22676
22029
22895
22917
22920
22058
22847
22852
22655
22708
22275
22254
22928
22857
22208
22071
23130
22092
22175
21194
23602
23018
23019
22076
22630
21108
22919
22825
22054
22177
20105
22998
20115
22104
22966
23625
23627
22748
22352
22353
22354
22618
21004
21005
22136
23059
22914
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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 |
Anastasia Sokolova 610-219-4834
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Manufacturer Reason for Recall |
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
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FDA Determined Cause 2 |
Software design |
Action |
An URGENT: MEDICAL DEVICE CORRECTION dated 1/31/22 was sent to customers.
What is the impact on system operation and what are the potential risks?
If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
What steps can the user take to avoid the potential risks associated with this issue?
It is highly improbably that the user will experience the described issue. However, it is recommended to follow regular cautions and instructions listed in the system operator manual, particularly in the chapter Safety , section Information about unit movements . Users and all accompanying personnel are advised to remain outside the zone of potential device movement, e.g., potential movement area of longitudinal and transversal direction of the ceiling stand.
How will the corrective action be implemented and how effective is the corrective action?
Siemens Healthineers is distributing a Customer Safety Advisory Letter XP046/20/S to all affected customers. A field software update for Ysio units that will eliminate the described issue will be distributed via an Update Instruction XP045/20/S. Apart from the described correction, the updated software contains further stability, usability, and performance improvements.
This resolution will be provided free of charge and is planned to be available in the first quarter of calendar year 2022. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800- 888-7436. Following the corrective action, the cause is eliminated and any recurrence of this potential fault is prevented
Acknowledge Receipt of this Safety Advisory Notice
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisor |
Quantity in Commerce |
70 Systems |
Distribution |
US Nationwide. |
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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