Recall Z-2619-2024 ยท FSY Light, Surgical, Ceiling Mounted
DKK Dai-Ichi Shomei Co., Ltd.
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
| Date | Aug 14, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. |
| Root cause | Process control |
| Action | On July 9, 2024 URGENT: Aurora 7 Lighthead Series RECALL letters were sent to customers. Actions to be taken by the customer: Contact the end users and tell them to discontinue the use of the product. Please send an acknowledgement letter or email to Dai-ichi Shomei to let us know that you have received this Field Action Advisory Notice within 3 days after you receive the Notice. Actions to be Taken by the Manufacturer: The physical correction will be announced later. Contact information for questions: email info@hospilite.co.jp |
| Quantity | 822 units |
| Distribution | Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071698 | AURORA LED SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc., Jul 6, 2007 |