Date Initiated by Firm |
June 18, 2021 |
Create Date |
September 24, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2561-2021 |
Recall Event ID |
88426 |
510(K)Number |
K173489
|
Product Classification |
Insufflator, hysteroscopic - Product Code HIG
|
Product |
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 |
Code Information |
Serial Numbers:
1709VG0832
1803CE0680
1803CE0681
1803CE0682
1803CE0683
1803CE0684
1803CE0685
1803CE0686
1803CE0687
1803CE0688
1803CE0689
1803CE1024
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2002CE0286
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2002CE0462
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2004CE0468
2004CE0469
2004CE0470
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2004CE0473
2004CE0474
2004CE0475
|
Recalling Firm/ Manufacturer |
WOM World of Medicine AG Salzufer 8 Berlin Germany
|
For Additional Information Contact |
+49 9263 877134
|
Manufacturer Reason for Recall |
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
|
FDA Determined Cause 2 |
Software design |
Action |
On 06/18/21 a recall notice was emailed to their one distributor customer. This customer was informed that a new software version was created that would alert the user when an inflow volume of 28.000 ml is reached. This is designed to prepare the user for manual determination of the deficit. The recalling firm recommends updating the units with the new software version during the next preventive maintenance at the recalling firm's U.S. location with the following contacts to coordinate shipment: Katrin.Glushko@novanta.com, 1-407-438-8810; Robert.Almeida@novanta.com, 1-407-472-1509 |
Quantity in Commerce |
1100 |
Distribution |
US Nationwide distribution in the state of CT. |
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 = HIG and Original Applicant = W.O.M. World of Medicine GmbH
|