SWISSRAY Medical, AG
HOCHDORF Luzern, CH
SWISSRAY Medical, AG appears in FDA device records in HOCHDORF Luzern, CH. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for SWISSRAY Medical, AG between 2005 and 2013. The busiest year on record is 2005, with 1. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131314 | DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) | MQB | Substantially Equivalent | |
| K123005 | DDRVERSA MOTION | MQB | Substantially Equivalent | |
| K110828 | DDRELEMENT | KPR | Substantially Equivalent | |
| K052943 | DDRFORMULA AND DDRFORMULA PLUS | KPR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614430 | 3002143662 | SWISSRAY Medical, AG | TURBISTRASSE 25-27, HOCHDORF Luzern CH 6280 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0697-2019 | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging. | A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured. | Class II | Terminated | |
| Z-3191-2018 | ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging | Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly. | Class II | Open, Classified | |
| Z-3248-2018 | ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging | Possible injury due to movement of the arm, calibration loss and communication loss. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain