Device recall
Z-0180-2010: Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-0180-2010 |
|---|---|
| Recall event | 53083 |
| Product | Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE Patient Management system is intended for use… |
| Product code | LWS |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2012 |
| PMA numbers | P910077, P910077S092 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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