Home › Device types › MEQ
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA product code MEQ · Class 3 · Unknown
13
Registered devices
1,248
Adverse events
9
Recalls
0
510(k) clearances
Devices with this code
Targis — Urologix LLCCoreTherm — Prostalund ABCoreTherm — Prostalund ABCoreTherm — Prostalund ABCoreTherm — Prostalund ABTargis — Urologix LLCCoreTherm — Prostalund ABTargis — Urologix LLCTargis — Urologix LLCCoreTherm — Prostalund ABCoreTherm — Prostalund ABTargis — Urologix LLCCoreTherm — Prostalund AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-28 | Urologix, Inc. | Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure K |
| 2010-02-18 | Urologix, Inc. | Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall |
| 2009-07-20 | Boston Scientific Corporation | Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. C |
| 2007-03-16 | Urologix, Inc. | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
| 2007-03-16 | Urologix, Inc. | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
| 2006-05-04 | Celsion Corporation | A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may |
| 2006-03-22 | Celsion Corporation, Inc. | Surgical treatment kits containing medical device components were mislabeled with extended expiration dates. |
| 2004-07-19 | Celsion Corporation | Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient. |
| 2003-12-10 | Urologix, Inc. | During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and |
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