VOLISTA StandOP Surgical Light recall
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF…
Why was VOLISTA StandOP Surgical Light recalled?
Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.
- Product
- VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF…
- Recalling firm
- Maquet SAS
- Quantity
- 151
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Tanzania, Yemen, and Zimbabwe.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)