ECHELON Oval MRI System
Recall
- Recall Number
- Z-2338-2021
- Event Number
- 88452
- Firm
- Hitachi Healthcare Americas Corporation
- FEI Number
- 1528028
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Vendor change control
- Initiated
- July 29, 2021
- Terminated
- September 8, 2023
- Address
- 1959 Summit Commerce Park, Twinsburg, OH, 44087-2371
Description
ECHELON Oval MRI System
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
On July 29, 2021, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. Customers were informed that the anti-skid area on the bottom of the table pads contain dry natural rubber. If a patient or user inadvertently comes into contact with the anti-skid material, it may cause allergic symptoms. If this occurs, immediately seek medical care for the user or patient. The firm does not require any additional action by the user at this time. The firm will begin including revised labels and user manuals with newly manufactured systems which contain the required notification of the presence of dry natural rubber in the anti-skid area of the pads. The firm will not be taking any additional action for already distributed product. For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
472 (US); 10 (OUS) Total