Device recall
Z-3119-2011: Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia…
FDA device recall · Class II · Cincinnati Sub-Zero Products Inc
Key facts
| Recall number (Z-number) | Z-3119-2011 |
|---|---|
| Recall event | 59691 |
| Product | Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the… |
| Product code | DWJ |
| Recalling firm | Cincinnati Sub-Zero Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2013 |
| 510(k) numbers | K101148 |
| FEI number | 1516825 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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