FDA Device recall Z-1990-2015
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the…
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the… by Maquet Cardiovascular Us Sales, citing maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1990-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
Reason
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
Identifiers
| code_info | Dual Arm: Part #569710902 - Serial Numbers: 15664, 15672 thru 15673, 15738 thru 15739, 15791, 15803, 15818 thru 15819,…Dual Arm: Part #569710902 - Serial Numbers: 15664, 15672 thru 15673, 15738 thru 15739, 15791, 15803, 15818 thru 15819, 15822 thru 15823, 15830, 15834 thru 15835, 15881, 15889, 15981, 16016, 16019, 16058 thru 16064, 16066 thru 16067, 16120, 16284, 16286 thru 16287, 20076 thru 20077, 20142, 20151 thru 20152, 20155 thru 20157, 20193 thru 20194, 20216 thru 20220, 20249, 20256, 20258, 20263, 20270 thru 20271, 20277, 20292, 20300 thru 20301, 20304, 20337 thru 20338, 20342 thru 20343, 20350, 20464, 20504 thru 20506, 20508 thru 20511, 20523, 40002 thru 40003, 40014 thru 40015, 40031 thru 40032 and 40034. Part #567910904 - Serial Numbers: 13177, 13190 thru 13191, 13204, 13208, 13217, 13219 thru 13220, 13232, 13235 thru 13236, 13249, 13251 thru 13252, 13254 thru 13255, 13257 thru 13260, 13288, 20004, 20008, 20061, 20063, 20065 thru 20072, 20111 thru 20115, 20119 thru 20120, 20122, 40001 thru 40002 and 40011 thru 40013. Part #567910906 - Serial Numbers: 14509 thru 14510, 20014, 20085, 2009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1990-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.