Recall Z-0186-2010 ยท FSY Light, Surgical, Ceiling Mounted
MAQUET Inc.
XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
| Date | Nov 12, 2009 (initiated Oct 7, 2009) |
| Status | Terminated |
| Reason | Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. |
| Root cause | Device Design |
| Action | Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative. |
| Quantity | 54 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM Alm S.A., May 21, 2004 |