Recall Z-1349-2018 ยท FSY Light, Surgical, Ceiling Mounted
GETINGE US SALES LLC
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
| Date | Apr 10, 2018 (initiated Feb 7, 2018) |
| Status | Terminated |
| Reason | The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure. |
| Root cause | Component design/selection |
| Action | The firm, Getinge, sent an "URGENT MEDICAL DEVICE RECALL" Notice dated 2/7/2018 to all affected consignees via mail. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Ensure that all users of the device are made aware of this field correction. 2) Check the device serial number against the list of affected serial numbers. 3) Contact the recalling firm to arrange for servicing of all affected units. Getinge Customer Service: (800) 950-9912, 8AM - 5PM (EST) Monday to Friday. 4) Complete and sign the enclosed customer response |
| Quantity | 5214 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Est |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130513 | VOLISTA 400; VOLISTA 600 Maquet S.A.S., May 8, 2013 |