RecallRadar

FDA Device recall Z-3083-2017

CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj

On 2017-09-06 the FDA classified a Class II recall of CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj by Med Tec, citing rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3083-2017
ClassificationClass II
Statusterminated
Initiated2017-08-10
Published2017-09-06
Last updated2026-09-13 11:54 UTC
CompanyMed Tec
DistributionIL, MI, TX

Product

CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

Reason

Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

Identifiers

code_infoCodes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3083-2017%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.