Recall Z-1158-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1158-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-13

Class I · Ongoing

Class I FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-01-13. It names 4 FDA 510(k) clearances: K200917, K172822, K163715 and 1 more. Product: Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.. Reason: Possibility of the patient falling from the table related to the mattress used on the patient table..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class I
Status: Ongoing
Initiated: 2025-01-13
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

4 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01
K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V.·cleared 2017-11-22
K163715 — Allura Xper R9Philips Medical Systems Nederland B.V.·cleared 2017-01-26
K033737 — ALLURA XPER FD20Philips Medical Systems North America, Inc.·cleared 2003-12-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Data sourced from openFDA. This site is unofficial and independent of the FDA.