Home › Philips Medical Systems Nederland B.V. › Philips
Philips
Philips Medical Systems Nederland B.V. · Model 989603207293 · UDI-DI 00884838118775
0
510(k) clearances
2
Adverse events
8
Recalls
15
Facilities
Description
Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Grid Block Assembly; 3 Grid Plate Enhanced Access, Lateral; 3 Grid Plate, Enhanced Access Medial; 2 IMMOBILIZATION SYSTEM, M/L, LBS ENHANCED; MRI Needle Block 12G; MRI Needle Block 14G; MRI Needle Block 18G; 2 Needle Block Holder; MRI Needle Block 16G.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
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.