Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Enforcement
- Recall Number
- Z-0728-2024
- Event ID
- 93595
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oakworks Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 24, 2024
- Initiation Date
- December 5, 2023
- Classification Date
- January 12, 2024
- Address
- 923 E Wellspring Rd, N/A, New Freedom, PA, 17349-8408, United States
Description
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Backrest platform stress fracture - the table is not operational in an inclined position
(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
US Nationwide Distribution
104 units