FDA establishment 2518586, Reedsville, Pennsylvania, United States. Part of Philips Ultrasound's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Mar 13, 2025 | Devices · Compliance: DevicesDevices · Radiation Control and Health Safety Act | 4 cited references
| Official Action Indicated (OAI) |
| Sep 5, 2012 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Philips 3D6-2 Ultrasound TransducerDevice · Z-1618-2026 · 11 products | Class III | Sep 5, 2025 |
| 3D6-2 Transducer ProbeDevice · Z-2346-2025 · 69 products | Class III | Jul 3, 2025 |
| Philips 3D9-3v Transducer.Device · Z-2048-2025 · 21 products | Class II | May 28, 2025 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Reedsville, Pennsylvania, United States. Part of