DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniot
FDA device recall Z-2971-2018 · posted 2018-09-17 · Terminated
Recall details
- Recalling firm
- Pro-Med Instruments Gmbh
- Reason for recall
- The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
- Action taken
- The firm initiated the recall by email on 07/05/2018. This stage is only relevant for hospitals / users who are in possession with concerned products of two different revisions (mix-up): a) Discontinue the use of the combination and quarantine the concerned products b) Contact pro med instruments for further instructions relating to temporary replacement possibilities
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HBL
- Quantity affected
- 31 units
- Distribution
- Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan
- Date initiated
- 2018-07-05
- Date posted
- 2018-09-17
- Date terminated
- 2020-11-19
- Location
- Freiburg Im Breisgau, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) (K032331) | Pro-Med Instruments GmbH | 2003-11-20 |