Recall Z-1860-2025 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Pro-Med Instruments Gmbh
DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
| Date | May 28, 2025 (initiated Mar 14, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On March 14, 2025 URGENT FIELD SAFETY NOTICE letters were emailed to distributors and customers. 5. Actions to be taken by the Customer/User: If you receive this Field Safety Notice from pro med instruments GmbH, part of Black Forest Medical Group, you have been identified as a hospital or user that have been supplied with the concerned product. The hospitals/ users who are in possession with the concerned product are kindly requested to - review this notification and ensure that all your affected products are identified and removed from use. - discontinue the use of the concerned product. - c |
| Quantity | 217 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001808 | DORO HEADREST SYSTEM Pro-Med Instruments GmbH, Aug 4, 2000 |