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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-0728-2024
Recall Event ID 93595
Product Classification Table, examination, medical, powered - Product Code LGX
Product Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Code Information (UDI): , 00817463025439 S/N: USW821950 USW821951 USM838906 USM838908 USM838909 USM838910 USM838911 USM838912 USW833604 USW803220 USW810646 USM802363 USM802364 USM802365 USM802366 USM802367 USM802368 USM802369 USM802370 USM802371 USM802372 USM802373 USM806418 USM806419 USM824495 USW824575 USW824576 USW835742 USW835743 USW835744 USW835745 USW835870 USW835871 USW805335 USW805500 USW814481 USW814489 USW814490 USW814491 USM818829 USM818830 USW834435 USW834436 USW834437 USW834438 USW837136 USW837137 USW837138 USW837139 USW837140 USM834172 USW825108 USW836285 USW825254 USW825255 USW825256 USM832158 USM837032 USM805639 USM805640 USW809784 USW809785 USW810360 USM810619 USW811819 USW825625 USW825626 USW833747 USW806381 USW809243 USW810505 USM814053 USM814054 USM814055 USW829084 USW838113 USW838114 USW807763 USW800305 USM812019 USM812024 USM820560 USW832338 USM827491 USM805539 USM813172 USM813173 USM806277 USW817676 USW817677 USW818075 USW829140 USM809220 USM809200 USM809202 USM797137 USM819374 USM819375 USM819376 USM819377 USM819378 USM819379 USM819381 USM819382
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 104 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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