OASIS MRI System
Reported: September 1, 2021 Initiated: July 29, 2021 #Z-2339-2021
Product Description
OASIS MRI System
Reason for Recall
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.
Details
- Recalling Firm
- Hitachi Healthcare Americas Corporation
- Units Affected
- 472 (US); 10 (OUS) Total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
OASIS MRI System. Recalled by Hitachi Healthcare Americas Corporation. Units affected: 472 (US); 10 (OUS) Total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2339-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11