Stryker Visum 300 Ceiling-mounted Exam Light Recalled for Weld Defect
Stryker Communications is recalling 1,375 Visum 300 Ceiling-mounted Exam Lights due to a potential incomplete final weld on the drop tube flange.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect (incomplete weld) in a medical device that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Communications is recalling 1,375 units of the Stryker Visum 300 Ceiling-mounted Exam Light. The recall is due to a potential incomplete final weld on the drop tube flange.
The affected products were distributed worldwide, including nationwide in the United States and to Canada. The units were shipped prior to February 28, 2013, and are identified by part numbers 0682001410A through 0682001410H.
Consumers and healthcare facilities should contact Stryker Communications for further instructions regarding the recall and potential replacement or repair of the affected equipment.
The recalled product
- Product
- Stryker Visum 300 Ceiling-mounted Exam Light.
- Manufacturer
- Stryker Communications
- Affected units
- 1,375
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 (9)
- Product sold under the following part numbers: 0682001410A
- 0682001410B
- 0682001410C
- 0682001410D
- 0682001410E
- 0682001410F
- 0682001410G
- and 0682001410H and shipped prior to February 28
- 2013.
Distribution
Distribution scope not specified by the agency.
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