Device 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.
Z-3083-2017
Product summary
- Firm
- Med Tec Inc
- Event
- Event 77874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-3083-2017
Official wording
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.
Code information: Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810
Distribution pattern: Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
Derived failure modes
-
Unknown
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.