Device recall
Z-0527-2014: Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1…
FDA device recall · Class II · Karl Storz Endoscopy America Inc
Key facts
| Recall number (Z-number) | Z-0527-2014 |
|---|---|
| Recall event | 66862 |
| Product | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension… |
| Product code | ECQ |
| Recalling firm | Karl Storz Endoscopy America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2014 |
| 510(k) numbers | K832010, K954797, K981458 |
| FEI number | 2020550 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database