Recall Z-0039-2012 ยท IDO Microtome, Rotary
Richard-Allan Scientific Company
Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
| Date | Oct 12, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | The firm has received two complaints of finger lacerations in operators of this device. |
| Root cause | Device Design |
| Action | ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of r |
| Quantity | 786 |
| Distribution | Worldwide Distribution: Nationwide distribution; including the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.