Recall Z-1075-2017— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2016-12-12, terminated 2019-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.. Reason: Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-12
- Terminated
- 2019-03-22
- Firm location
- Montvale, NJ, United States
Product description
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Reason for recall
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Data sourced from openFDA. This site is unofficial and independent of the FDA.