i-view video laryngoscopes may be faulty because of depleted batteries
The i-view video laryngoscope is being recalled because of the potential for faulty devices as a result of depleted batteries. 2,152 pieces are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The i-view video laryngoscope, model number 8008000, indicated to facilitate laryngoscopy, is being recalled. The action covers 2,152 pieces, with case UDI-DI 05030267166497 and single unit UDI-DI 5030267150649.
The stated reason is the potential for faulty devices as a result of depleted batteries. The FDA classified the action as Class I, its most serious classification.
Distribution was in Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Pennsylvania, South Carolina and Texas among other states. The devices are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
- Manufacturer
- Intersurgical Inc
- Affected units
- 2,152
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1240793.
Distribution
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