Recall Z-1860-2025— Pro-Med Instruments Gmbh

Name: FDA recall Z-1860-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-14

Class II · Ongoing

Class II FDA medical device recall by Pro-Med Instruments Gmbh, initiated 2025-03-14. It names one FDA 510(k) clearance: K001808. Product: DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002). Reason: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded..

Recalling firm: Pro-Med Instruments Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2025-03-14
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K001808 — DORO HEADREST SYSTEMPro-Med Instruments GmbH·cleared 2000-08-04

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

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Reason for recall

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

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