Home › Bard Access Systems, Inc. › Site~Rite
Site~Rite
Bard Access Systems, Inc. · Model Version 1.2.1 · UDI-DI 00801741231193
1
510(k) clearances
4,104
Adverse events (23 deaths)
147
Recalls
399
Facilities
Description
SR9v1.2.1 - Site~Rite 9 Ultrasound Software
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-17 | Sheathing Technologies Inc | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.