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U.S. Department of Health and Human Services

Class 2 Device Recall Oakworks Ultrasound EA Table

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  Class 2 Device Recall Oakworks Ultrasound EA Table see related information
Date Initiated by Firm December 05, 2023
Date Posted January 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-0727-2024
Recall Event ID 93595
Product Classification Table, examination, medical, powered - Product Code LGX
Product Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Code Information (UDI): 00817463025323 S/N: Serial Number USE837298 USE837299 USE832277 USE832279 USE812943 USE814317 USE799725 USE799726 USE799727 USE799730 USE799732 USE802575 USE802576 USE811024 USE811257 USE811258 USE811259 USE811260 USE811261 USE812704 USE813219 USE813603 USE818072 USE819626 USE824702 USE825956 USE825957 USE825958 USE825959 USE825960 USE826294 USE829080 USE829705 USE829706 USE829707 USE829708 USE829709 USE829710 USE832003 USE832004 USE832005 USE832006 USE832007 USE834846 USE835241 USE835242 USE835476 USE835776 USE836792 USE836879 USE836880 USE836881 USE836882 USE813594 USE813595 USE817820 USE839073 USE839074 USE839075 USE839076 USE814826 USE814827 USE814828 USE814829 USE814830 USE827308 USE803256 USE803299 USE803300 USE805960 USE805961 USE805962 USE809599 USE812579 USE815868 USE815908 USE817060 USE817061 USE818707 USE822030 USE824612 USE826254 USE828213 USE828214 USE829403 USE832116 USE832990 USE833712 USE833713 USE833960 USE838977 USE838254 USE805081 USE805082 USE818815 USE806583 USE811236 USE818243 USE819259 USE825037 USE835200 USE818139 USE818140 USE835527 USE835528 USE809360 USE811590 USE801767 USE805493 USE805494 USE805495 USE805794 USE805795 USE806093 USE806343 USE806782 USE806783 USE806784 USE807732 USE807827 USE807828 USE807832 USE807833 USE807834 USE807835 USE807836 USE807837 USE808960 USE808961 USE808962 USE809182 USE809631 USE809632 USE810336 USE810546 USE813715 USE813912 USE813913 USE813914 USE814416 USE814417 USE814418 USE816892 USE817024 USE817174 USE817457 USE817675 USE819750 USE822988 USE822989 USE823802 USE831280 USE831313 USE832776 USE834440 USE834875 USE834876 USE835877 USE836209 USE838838 USE838920 USE813405 USE805279 USE805280 USE805281 USE809749 USE809750 USE809751 USE809752 USE812563 USE812564 USE812565 USE812566 USE814568 USE817617 USE820048 USE833660 USE834269 USE835798 USE835799 USE835800 USE835801 USE835802 USE835803 USE835804 USE830284 USE811539 USE812084 USE816038 USE803752 USE801427 USE803589 USE839292 USE813104 USE813719 USE810378 USE810379 USE835126 USE838175 USE817021 USE839597 USE839598 USE818132 USE818133 USE818134 USE818135 USE818136 USE818137 USE818138 USE802125 USE826701 USE831873
Recalling Firm/
Manufacturer		 Oakworks Inc
923 E Wellspring Rd
New Freedom PA 17349-8408
For Additional Information Contact Stephen McKinley
717-235-6807
Manufacturer Reason
for Recall		 Backrest platform stress fracture - the table is not operational in an inclined position
FDA Determined
Cause 2		 Device Design
Action Oakworks Inc. issued "URGENT: MEDICAL DEVICE RECALL/CORRECTION" letter on 12/5/23 via Certified Mail/Email to Distributors and End Users. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory of OAKWORKS¿ Inc. Ultrasound EA Table with Echocardiography, or Electric Access Back Supports [left & right] to identify and locate all affected product(s). 2. For tables in use, they remain fully functional if the backrest platform stress fracture has not occurred. For tables that have the stress fracture or break, only use in a flat position until the backrest is replaced. 3. Implement the field action as described below for the product listed in the Product and Distribution Information Table. 4. Enclosed is a Medical Device Advisory Notice Response Form for each product we believe you have. Please complete this form in its entirety and return to OAKWORKS¿ Inc., within 48 hours of receipt of this advisory notice via any of the options listed below. MAIL: Oakworks Inc. EMAIL: customerservice@oakworks.com Attn: Customer Service MDAN Response 923 East Wellspring Rd. New Freedom, PA 17349 Action by OAKWORKS¿ Inc.: Upon receipt of the Medical Device Advisory Notice Response Form(s), and to minimize the downtime of your OAKWORKS¿ Ultrasound EA table, we will setup a service visit to replace the backrest (if a stress fracture has occurred) or install a reinforcement plate (if a stress fracture has not occurred) on the table(s). The correction installation takes approximately 30 minutes. The replaced backrest will be disposed of by the service provider. Additional Information: If you have any questions or concerns, please contact our Customer Service Department at 800-558-8850 or 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
Quantity in Commerce 212 units
Distribution US Nationwide Distribution
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.
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