CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
Volista StandOP recalled by Maquet SAS
Maquet SAS is recalling Volista StandOP (, distributed nationwide in the US. The recall was initiated on 19 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1937-2018
- FDA event ID
- 79898
- Recalling firm
- Maquet SAS, Orleans, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2018
- FDA classified
- 25 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 19 Apr 2018 | Recall initiated by company | |
| 25 May 2018 | Classified by FDA | +36 days |
| 6 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential keypad failure on VOLISTA StandOP Surgical Lights.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, TZ, YE, ZA, ZW).
Nationwide ArkansasCaliforniaColoradoDelawareIndianaPennsylvania
Questions about this recall
Why was it recalled?
Potential keypad failure on VOLISTA StandOP Surgical Lights.
Which lots are affected?
Serial Numbers: 38013 38016 500641 500644 25002 35025 35028 38012 38015 500000 500001 500003 500004 500014 500015 500016 500018 500037 500039 500020 500060 500063 500642 500643 31053 500058 38009 38026 31002 31030 31048 31054 21001 21002 35024 35012 35013 35014 35015 38017 500001 500017 35029 35017 35027 31019 31020 31022 31024 31025 31026 31000 31000 31001 31002 31003 31006 31009 31010 31012 31008 31047 31050 31051 31052 500002 500060 500061 500072 500073 500680 500685 500686 500687 500692 510082 500062 500064 500042 500044 31012 31013 31014 31020 38011 38014 31006 31008 31015 31016 500068 500070 500071 500074 31021 31023 38018 38019 38020 38021 38022 38023 38024 38025 31004 35011 31004 31017 31018 35000 35001 35018 35019 35020 35021 35022 35023 35026 35030 35031 35032 35033 38027 31001 31003 28003 28004 25005 25006 500055 500059 500011 500013 25007 25004 31039 31040 31041 31042 31043 31044 31045 31046 31055 31056 31005 31009 31011 31017 31019 38025 38026 38027 38028 500065 500066 500067 500069 38000 38002 500002 500005 500010 500012 500056 500059 38001 38003 31031 31049 20502 20503 500075 500076 500609 500610 500611 500612 500613 500614 500615 500616 500617 500618 500619 500620 500066 500067 500068 500069 500070 500071 500072 500073 510007 510008 510009 510010 510011 510012 510013 510014
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, TZ, YE, ZA, ZW).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet SAS
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PowerLED 300 Concealed Lighting System recalled by Maquet SAS | Maquet SAS | Other | Nationwide |
| Device | CLASS II | Volista StandOP Surgical Light, ARD568811961 VLT600DF AIM STP recalled | Maquet SAS | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Hip Scope Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |