ProxiDiagnost N90
Reported: October 7, 2020 Initiated: November 20, 2019 #Z-3023-2020
Product Description
ProxiDiagnost N90
Reason for Recall
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 71
- Distribution
- United States
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
ProxiDiagnost N90. Recalled by Philips North America, LLC. Units affected: 71.
Why was this product recalled? ▼
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3023-2020.
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