Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24956 |
| Brand Name: | CSZ - Hyperthermia system, heated fluid |
| Model: | Norm-O-Temp Hyperthermia System, Models 111Z and 111W: MICRO-TEMP LT System, Model 749: Blanketrol II Hyper-Hypothermia System, Models 222R and 222S: Blanketrol III Hyper-Hypothermia System and CoolBlue Hyper-Hypothermia System, Models 233 and Innercool |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Paragon Medical Ltd t/a LR Instruments and Scanmedics Immulab & Insight Surgical Level 2 Bldg. 5 60 Highbrook Drive East Tamaki Auckland 2013 |
| Contact Information: | 0800 150 030 |
| Manufacturer: | Cincinnati Sub Zero Products Inc |
| Issue: | The manufacturer is updating the warning section in the Operation Manual to alert the users that the use of the product exceeding 40°C for extended periods may cause tissue damage. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/8/2019 |
