Z-1784-2019Class II
TASE 500 Imaging systems
Collins Aerospace / initiated 2019-01-29 / Open, Classified
COLLINS AEROSPACE began a recall of TASE 500 Imaging systems on . FDA classified it as Class II and gives the reason as "the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1784-2019
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Collins Aerospace
- Product
- TASE 500 Imaging systems
- Product code
- RET Laser Target Designator
- Reason for recall
- the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
- FDA root cause
- Radiation Control for Health and Safety Act
- Action
- Collins Aerospace sent a customer notification letter to affected customers,. The letter identified the affected product problem and actions to be taken. For questions contact Customer Support Team at [email protected]
- Quantity in commerce
- 433 in total
- Distribution
- US Nationwide Distribution
- Product codes and lots
- TASE 500
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1783-2019 | Class II | Ongoing | FDA Mandated | ||
| Z-1784-2019 | Class II | Ongoing | FDA Mandated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
